Pharmacovigilance Scientist (Gauteng) at Aspen Pharma Group

KEY RESPONSIBILITIES

Key Accountabilities

• Delegated tasks from RA Manager or PV Lead on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representation at meetings when required.
• Functional reporting: Mentoring of the Pharmacovigilance Officers and Medical Writers.
• Review and advice regarding relevant local and global guidelines, policies, internal procedures and SOPs across Aspen Pharmacare.
• Maintain awareness of Pharmacovigilance regulatory requirements and developments.
• Manage outsourced data collection, organisation and preparation with vendors. 
• Act as Subject Matter Expert (SME) in designated area (e.g. literature, signal management, aggregate reports, labelling etc.) responsible for oversight and coordination of tasks related to the area of expertise.
• Preparation of annual as well as ad-hoc and scheduled aggregate safety reports.
• Ensure Good Documentation Practice.
• Contribute to agreed PV Team quality and compliance targets.
• Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs.
• Direct interaction with Regulatory Authorities.

Financial

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

Medical Writing Accountabilities

• Work in collaboration with Medical Writers to write clinical documents for submission to regulatory authorities, including but not limited to:
• clinical overviews and summaries
• integrated summaries of safety and efficacy
• Clinical Expert Statements
• Provide medical editing review of draft and final documents prepared by other team members before internal or external distribution. This includes both copy editing and content review.
• Ensure document content and style adheres to SAHPRA/FDA/EMA or other appropriate regulatory guidelines and complies with Aspen SOPs and style guidelines
• Perform literature searches/reviews as necessary to obtain background information and training for development of documents.

Safety

• ICSR (Individual Case Safety Reports)
• Ensure all cases are processed, medical reviews completed, and cases submitted to Health Authorities as per the timelines specified in the guidelines.
• Ensure quality checks are performed on weekly, monthly, quarterly and bi-annual reconciliations with internal and external stakeholders.
• Labelling
• Updating and reviewing Product Information in line with the Company Core Data Sheets, and other tasks as designated.
• 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 and Risk Communication Plans.
• Request for Information (RFI) from Competent Regulatory Authority (CRA) and Safety Communication (Dear Healthcare Professional Letter (DHCPL)
• Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly.
• Literature Reviews
• Monitor local literature for designated products and identify safety issues/ ICSRs in a timely manner.
• Signal detection
• Coordinate and prepare appropriately for signal management meetings.
• Signal Management Activities including compilation of Signal Assessment Reports/ Case 
• Series Reviews for potential signals.
• Safety Data Exchange Agreements (SDEAs)
• Creation and update of Safety Data Exchange Agreements (SDEAs).

Training

• Oversee training and mentoring of other Pharmacovigilance staff, and prepare training materials 
• Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
• Maintain a high and up-to-date level of product and therapy area knowledge by attending conference, training courses, reading relevant medical and scientific literature

QMS

• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs
• Creation and update of SOPs/WIs for all pharmacovigilance activities related to the job role in line with Pharmacovigilance regulations/guidelines (EU, ZA and other territories applicable), within specified/SOP timelines.

General

• 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

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.

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

EDUCATION & EXPERIENCE

• Matric
• Biological/life Sciences Degree or equivalent
• B. Pharm would be advantageous.
• Documented experience in all aspects of pharmacovigilance is an inherent requirement and not negotiable.
• 3-5 yrs. pharmaceutical experience with specific focus areas in PV/Drug Safety
• Experience working with safety databases.
• Experience writing large safety reports e.g., DSURs, PADERs, PSURs, PRBRERs is preferable.
• Experience in writing RMPs is desirable.
• Experience working with MedDRA coding dictionary.