Pharmacovigilance Officer - JHB at Aspen Pharma Group

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 Digital).

Reconciliation

• Reconciliation of all adverse event reports received by PV from internal stakeholders (QA/MIC 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 Digital.

Aggregate Reporting and Regulatory Intelligence

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

 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

KNOWLEDGE

• Knowledge of relevant information sources including: printed publications, unpublished sources, databases, websites, social media sites and external bodies.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

Requirements

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 year).
• GCP training advantageous 

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 customers.
• 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