OBJECTIVE OF ROLE

• To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring successful Marketing Authorization and variation approval from the SAHPRA and Regulatory Authorities of the SADC member states within the committed timeframe.
• The role undertakes responsibility for compliance with the Regulatory / Pharmacovigilance Requirements for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan.
• To provide support to the Pharmacovigilance Lead for the various Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all Aspen products across Pharmacare and any other entity owned by Aspen, of the Aspen Group for which marketing authorizations are held. The role undertakes responsibility for coordinating and managing of review and analysis of aggregate safety data concerning the Aspen Group product portfolio.

KEY RESPONSIBILITIES

Key Accountabilities

• Delegated tasks from RA Manager or PV Lead on a defined and ad hoc basis with the flexibility of mindset and time resources 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, organization, and preparation with vendors.
• Act as Subject Matter Expert (SME) in designated areas (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 be escalated to the departmental line management and the financial impact thereof.
• Project management of contractual and financial aspects of all medical writing projects and the effective utilization 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 Statement
• 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 adhere to SAHPRA/FDA/EMA or other appropriate regulatory guidelines and comply with Aspen SOPs and style guidelines
• Perform literature searches/reviews as necessary to obtain background information and training for the 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.
• 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.
• 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 conferences, training courses, and 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’s core values
• Effective management and utilization of resources to keep processes cost-effective
•  Collating data for ad hoc requests
• Adherence to Company Health & Safety Procedures
• Participate in training programmers and any other duties assigned by your Manager

Requirements
EDUCATIONAL REQUIREMENTS

• Biological / life Sciences Degree or equivalent
• B. Pharm would be advantageous

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• Documented experience in all aspects of pharmacovigilance is an inherent requirement and not negotiable
• 3-5 yrs. Pharmaceutical experience with a 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 the MedDRA coding dictionary
• 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

SOFT SKILLS REQUIREMENTS

• Results and performance driven
• Strong work ethic and integrity
• 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 proactive 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
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexibility & confidentiality are key requirements for this role.