Job Openings at Aspen Medical

About the Job
MAIN DUTIES

FINANCIAL

• Effective utilization of resources to keep procedures cost effective

CUSTOMER

• Display a professional attitude when responding to customers
• Propose, develop and update methods to improve customer services
• Effective liaison and communication with internal and external customers, including but not limited to Regulatory Authorities, External consultants and Agents, Quality Assurance, Project managers, Artwork, New Product Launches, Manufacturing Sites, Pharmacovigilance, Medical Information, AGI, APTL,

Liaise as necessary with:

QUALITY MANAGEMENT

• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOP’s.

DUE DILIGENCE

• Perform due diligence on new IP identified for licensing/acquisition to identify deficiencies in the IP relating to SAHPRA laws and regulations, in compliance with timelines in licensor/purchaser agreements
• Raise all risks and critical issues with line manager at DD stage before issuing DD report
• Request CCDS/PI, frills, samples, etc. from the relevant departments as per process, within specified timelines
• Follow up with stakeholders on DD requests until finalization of outstanding matters, ensuring a quality and compliant submission.

NEW REGISTRATION APPLICATIONS

• Use Veeva RIM and dedicated I-drive to compile quality dossiers which are compliant with SAHPRA requirements, guidelines, regulations, and internal departmental procedures, within the allocated timelines, ensuring smooth progression to Marketing Authorisation
• Raise any minor additional data requirements identified at compilation stage so as not to compromise proposed submission date
• Ensure required fee is paid to SAHPRA
• Ensure relevant support personnel are asked timeously to prepare the electronic or hard copy submission, over-see and review such activities
• Ensure proof of receipt from SAHPRA is received and recorded
• Update and maintain all appropriate trackers, databases and systems as required to ensure visibility and accurate reporting
• Attend to action items in Trackwise to ensure compliance with completion/closeout timelines.

RESPONSE TO SCREENING OUTCOMES AND RECOMMENDATIONS

• Compile and submit compliant responses to screening outcomes from SAHPRA by requesting additional data/frills/samples
• Over-see the compilation of post-screening copies, take responsibility, and sign relevant documentation after verifying quality/compliance of the response
• Over-see completion of administrative functions as per departmental procedures
• Compile and submit compliant responses to recommendations from the following Units, being aware of communicating risks to line manager:
• P&A Unit
• Inspectorate Unit
• Names & Scheduling Unit
• Action and close out Trackwise items
• Over-see completion of administrative functions as per departmental procedures

REGISTRATION

• Ensure new Marketing Authorisations are up to date with all pre-registration activities, including recommendations from all committees/ units.
• Ensure that all labelling components are updated with the registration details as per departmental procedures
• Ensure that translated labelling text is available if required as per country specific requirements
• Ensure that accurate labelling text is provided to the Artwork Department via the Pulse system, for implementation in the market
• Consider impact of registration details on shared packs
• Receive and review registration certificate for errors, and arrange correction
• Check for post-registration variations and notify line manager of these as per process
• Action and close out Trackwise items
• Over-see completion of administrative functions as per departmental procedures

PROJECTS

Coordinate and manage projects as required
TRAINING

• Provide technical and procedural training to the department in line with development needs
• Provide one on one training and coaching to less experienced staff and reviewing their work as required
• Perform peer review of New Product and Variation submissions compiled by RA Pharmacists, RA Officers and operational and strategic partners
• Provide technical expertise and guidance to operational and strategic partners (internal and external) in relation to on regulatory requirements, quality and processes for New Product and Variation / RFI submissions.

GENERAL

• Participate in cross-functional activities related to Regulatory requirements, quality and process and represent RA on project teams
• Adhere to agreed Key Performance Indicators (KPIs)
• Support the continuous development and improvement of the RA function while upholding Aspen core values
• Collating data for ad hoc requests
• Adherence to Company Health & Safety procedures
• Participate in training programmes
• Any other duties as assigned by line manager / HOD
• Active collaboration with the local Regulatory and Operations teams to ensure the appropriate flow of information and decisions
• Active collaboration with the Regional and Global teams, to seek advice, inputs and guidance, and work on any regional or cross-functional projects.
• Ensure compliance with all GxP as well as compliance with applicable local regulations.
• Keep abreast of developments in best practice and all RA, PV, MI, QA and related activities
• Maintain a high and up-to-date level of RA, PV, MI, QA and related areas of knowledge by attending conference, training courses, reading relevant medical and scientific literature.

Requirements

KNOWLEDGE

• A solid understanding of The Medicines and Related Substance Act 101 of 1965 and Regulations
• Comprehensive knowledge of SAHPRA Guidelines
• Knowledge of principles governing regulatory requirements such as ICH and WHO Technical knowledge of the CTD, eCTD
• Knowledge of project management principles
• Computer literate

SKILLS AND ATTRIBUTES:

• Good work ethic and ability to meet deadlines
• Good interpersonal skills
• Information seeking
• Business analysis and financial skills
• Problem-solving and good judgment
• Accuracy and Attention to detail
• Time Management
• Resource efficiency
• Risk management
• Responsibility and accountability
• Initiative
• Results oriented
• Systems thinking
• Planning and organisational skills
• Focused
• Informal communications skills
• Active listening skills
• Writing skills
• Presentation skills
• Empathy
• Flexibility and tolerance for ambiguity
• Transition management
• Capacity for and resistance to stress
• Ability to work under pressure
• Perseverance and tenacity
• Technical / professional knowledge
• Industry knowledge
• Curiosity / learning agility
• Self-awareness
• High standards

EDUCATION & EXPERIENCE:

• Bachelor of Pharmacy degree or equivalent
• Minimum 5 years’ experience in a Regulatory Affairs environment, including compilation and submission of new product applications in accordance with the latest requirements.
• Proven ability to do thorough peer review of New Product, RFI and Variation submissions, mentor junior staff and provide technical expertise and guidance.
• More than 2 years’ experience within the Pharmaceutical industry in a Production/Quality/Clinical environment a distinct advantage

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 23 April 2021. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.

Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their application.

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About the job
MAIN DUTIES

PHARMACOVIGILANCE SUPPORT

• ICSRs (Individual Case Safety Reports)
• Performing assessment of adverse event case reports.
• Act as case owner for assigned ICSRs to ensure accurate completion of data entry (DE), data review (DR) and regulatory reporting (RR), in line with current SOPs.
• The PVO acts as a product owner for products under the remit of Pharmacare, supporting the PV Scientists with literature management and aggregate report preparation.
• Maintain a high standard of case quality.
• The PVO is responsible for providing a root cause analysis for any late reporting submissions.
• Management and prioritisation of individual workload while maintaining good documentation practices (GDP).
• Highlighting any safety related issues to the attention of the management team.
• Perform pharmacovigilance checks/evaluations of the Quality Assurance database (Trackwise).

Reconciliation

• Reconciliation of all adverse event reports received by PV from internal stakeholders (QA/MI and ACC).
• Reconciliation of all adverse event reports received from PV service providers, affiliates, distributors and license partners monthly; quarterly or bi-annually as described in the Safety Data Exchange Agreement (SDEA).

Quality Systems Management

• Support preparation of SOPs, WIs, and product safety reviews
• Raising of compliance cards for late cases reported to Pharmacare by service providers, affiliates, distributors and license partners.
• Ensure all allocated CAPAs; Deviations and Actions are closed on time on Trackwise.

Aggregate Reporting and Regulatory Intelligence

• Keep abreast of changes to PV Legislation and ensure Regulatory Intel is monitored for ZA and SSA territories.

Basic PV training for all Aspen employees

• Contribute to the development of PV training.
• Pharmacovigilance training of all Aspen employees and distributors/service providers and documentation thereof.

Literature reviews

• Regulatory review key Medical Journals for any adverse drug reaction reports with Aspen Pharmacare products/medicines.
• Understand SDEA obligations in order to ensure all aspects under agreements are dully executed.
• Facilitate SDEA training (to employees as well as 3rd parties).

Signal management

• Highlighting any safety related issues to the attention of the management team
• Co-ordinate Safety Review meetings (monthly)
• Reviewing of Regulatory websites for any potential signals
• All other ad hoc PV activity duties as required by the business needs
• Adhere to agreed Key Performance Indicators (KPIs).
• Support the continuous development and improvement of the PV function while upholding Aspen core values.
• Receipt, evaluation and reporting of individual case safety reports in accordance with international (export territories) and local regulatory requirements and contractual partner obligations.
• Provide support to Global PV Global.

CUSTOMER SERVICE

• All queries are followed up and strictly within policy framework i.e. 48 Hours turn-around time.
• A professional attitude is displayed when responding to a customer’s needs.
• Methods for improving customer services are proposed.
• Internal and external customers are kept updated, under supervision, as to the progress of their queries
• Liaise on a daily basis with RA customers, i.e. SAHPRA, Marketing, Manufacturing sites, Quality-related departments, Public Health, Exports, Outsource, and relevant licensors and distributors.

FINANCIAL

• Identification of project challenges to departmental line management and the financial impact thereof

GENERAL

• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs·      
• Adhere to agreed Key Performance Indicators (KPIs)·      
• Support the continuous development and improvement of the PV function while upholding Aspen core values·      
• Effective management and utilisation of resources to keep processes cost effective·      
• Collating data for ad hoc requests·      
• Adherence to Company Health & Safety procedures·      
• Participate in training programmes ·      
• Any other duties as assigned by your Manager

Requirements

KNOWLEDGE

• Knowledge of relevant information sources including: printed publications, unpublished sources, databases, websites, social media sites and external bod
• Effective understanding and use of the principles of information capture, storage, searching and retriev
• Effective use of appropriate IT systems and program
• Understanding of relevant legal and related issues on copyright, codes of Practice, Data Protection legislation, regulations and guidelines.

SKILLS AND ATTRIBUTES:

• Business process analysis
• Report writing
• Information gathering and monitoring
• Projects (advantage)
• Ability to communicate information effectively and clearly in written form and orally, and at levels appropriate to the needs of different internal and external custome
• Integrity
• Work ethic
• Ability to meet deadlines
• Positive ‘can – do attitude’
• Work autonomously and have good problem-solving skills
• Able to cope with evolving deadlines effectively with regular feedback and updates
• Honest and trustworthy
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexible and confidentiality
• Positive and pro-active approach to business tasks
• Enthusiasm and drive to take ownership and drive process initiatives
   

EDUCATION & EXPERIENCE:

• Bachelors or Post Graduate degree in science, pharmacy or medicine, or Post Basic Pharmacist Assistant
• PV experience (2 years), experience in post-marketing reporting of AEs.
• Quality Assurance experience (1 years).
• GCP training advantageous.

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 23 April 2021. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.

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About the job
MAIN DUTIES

FINANCIAL

• Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost effective
• Identification of project challenges to departmental line management and the financial
• impact there

 PROJECT MANAGEMENT

• Act in the capacity of project manager/lead for medical writing projects.
• This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues, and other duties as assigned.   
• Project management of contractual and financial aspects to be performed with management where necessary.·      
• Serve as the Medical Writing representative to provide proactive support for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.  
• Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Pharmacare guidelines/SOPs.
• Coordinate production and distribution of draft and final documents to regulatory teams. Ensure that all work is complete and of high quality prior to team distribution.   
• Attend internal and technical team meetings as required.
• Assist management as needed with preparation of resourcing estimates for potential new medical writing projects.
• Proactively engage with other departmental resources where necessary to ensure that information/documentation requests are delivered in a professional and timeous manner. 

 MEDICAL WRITING ACCOUNTABILITIES

• Ensure defined framework as set by PV Manager or Head of Department are executed
• within the specified timelines.
• Write clinical documents for submission to regulatory authorities, including but not limited to:
• clinical overviews and summaries
• clinical expert statements
• interim and final clinical study reports
• integrated summaries of safety and efficacy
• nonclinical overviews and summaries
• Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content revie
• Ensure document content and style adheres to FDA/EMA/SAHPRA or other appropriate regulatory guidelines, and complies with departmental and corporate SOPs and style guidelines
• Perform literature searches/reviews to obtain background information and training for
• development of documents
• Prepare country specific packs for submission of safety variations within ZA and other
• territories
• Assist in the assessment of clinical and nonclinical documentation with regards to its suitability for supporting new marketing authorisation applications (MAA) or new indicati

SAFETY

Aggregate reporting

• Preparation of aggregate safety reports including but not limited to PSURs, PBRERs  and Addendum Safety Reports.

Risk Management System

• Preparation of Risk Management Systems including but not limited to Risk Management Plans, Dear Healthcare Professional Letters and Risk Communication Plans.

Request for Information from Competent Regulatory Authorities (CRAs)

• Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly.

 Signal Management

• Assessment of local PI/PIL for inclusion of the validated signal.
• Data analysis of signals and feedback to the Safety Review Team (SRT) during the Signal Management meetings

TRAINING

• Provide training and guidance and act as a mentor to less experienced departmental

me

• Initiate and participate in departmental or interdepartmental process improvement and training initiative
• Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow proced
• Assist in the development of departmental SOPs/W
• Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the depart

 GENERAL

•  Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs·      
• Adhere to agreed Key Performance Indicators (KPIs).
• Support the continuous development and improvement of the PV function while upholding Aspen core values.
• Maintain rigorous adherence to written procedures, e.g. SOPs/WIs. 
• Adherence to Company Health & Safety procedures.
• Participate in training programmes.
• Any other duties as assigned by your Manager.

Requirements

KNOWLEDGE:

• Strong knowledge of regulatory and medical authorities in South Africa
• Strong understanding of regulations, ICH guidelines, and GCP
• Extensive medical writing and expertise in submission

SKILLS AND ATTRIBUTES:

• Results and performance driven – deliver results that meet or exceed expectations
• Integrity
• Work ethic
• Ability to meet deadlines
• Sense of urgency – responding to issues and opportunities in a timely manner
• Intellectual curiosity – willing to suggest and try new ideas
• Positive and pro-active approach to business tasks
• Excellent interpersonal and communication skills
• A solutions provider
• Manage evolving deadlines effectively with regular feedback and updates
• Enthusiasm and Drive to take ownership and drive process initiatives
• Service orientation
• Customer focused
• Logical thinking
• Information seeking
• Positive ‘can – do’ attitude
• Be able to work autonomously and have good problem-solving skills
• Able to cope with evolving deadlines effectively with regular feedback and updates
• Honest and trustworthy
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexibility & confidentiality are key requirements for this role.

EDUCATION & EXPERIENCE:

• Sc. (Hons) or equivalent scientific qualification
• 4yrs experience in pharmaceutical clinical research expert
• Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 23 April 2021. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.