Job Description

Our client is searching for a Senior Pharmacovigilance Associate to join their team in Irene Centurion.

Job Profile

The Organisation is a rapidly growing global speciality pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely, on time and wherever they are needed in the world. As a Senior PV Associate, you will work within the Pharmacovigilance Operations Team and will be dedicated to one or more of our pharmaceutical clients with a truly global presence supporting the collation, processing and analysis of safety information on behalf of a Client(s) product(s); this unique industry-changing
relationship redefines collaboration. This role requires you to be a passionate pharmacovigilance professional, who is a dedicated and enthusiastic team player, who wants to work with a new business that strives to gain and maintain an exceptional reputation as a PV Service Provider who is knowledgeable, cares and produces high-quality work.

Key Responsibilities

For the Company

• Working within the Pharmacovigilance Operations Team.
• Assess and process serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) in the Global Drug Safety database.
• Experience and qualified to perform quality control of other PV Operations activities.
• Support quality and efficiency strategies within the organization.
• Support the Company by attending BID defence meetings.
• Support in the provision of regular updates regarding the status of specific project/ Client activities.
• Developing PV medical training presentations and delivering training, as required.
• Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in the PV inspections or audits.
• Contributes to improvements of team processes.
• Other PV operational activities or initiatives as assigned.
• Maintaining good client relations and ensuring a consistently high quality of work for each client.
• Mentoring and training of new PV staff as relevant.
• Support with relevant SOP authoring, ensure all contractual requirements with regards to Pharmacovigilance are updated in the relevant procedures, and contribute to and ensure system improvement.
• Review Medical Information Enquiries and Product Quality Complaints to ensure all safety information has been captured.
• Provide backup to PV Associates as required

For the Clients

• Managing mailboxes - responding to data entry/ case processing queries from Clients and Client Partners, responding.
• Support with QC of safety data management from client Managed Access Programmes.
• Ensure all internal and external queries are tracked/ professionally and efficiently responded to within stipulated timelines.
• Case processing of SAEs and/or ICSRs.
• Case regulatory reporting; preparing relevant cases for submission and sending them to the relevant Regulatory Authorities.
• Working on E2B/R3 format reporting and Case Finalization; reading error messages and taking steps to correct cases as a result of negative acknowledgements.
• Investigating cases of non-compliance of SAEs/ICSRs and supporting the development of non-conformances and corrective and preventative actions.
• Performing Literature Article Reviews.
• Performing follow-ups related to queries and requests regarding case handling.
• Communicating with Clients/ Partners regarding the evaluation and processing of ICSRs.
• Performing quality control of cases in the Global Drug Safety database.
• Expedited Reporting activities involving Work Instruction Updates, System Reporting Rules, Regulatory Intelligence, and Clinical Reporting Instructions Updates.
• Performing reconciliation activities as per Client contracts and each Client Operating Guideline (COG).
• Assists when required in Partner, Health Authority Audits/ Inspections.
• Participation in Client audits and inspections.
• Support the Safety Evaluation and Risk Management (SERM) team with aggregate PV data analysis for signal detection/ aggregate reporting purposes.

Requirements

• Healthcare Professional qualification or the equivalent of a Bachelor of Science (BSc) degree.
• Minimum 2 years experience of operating in a similar role is essential. Experience working in the pharmaceutical/healthcare/life sciences industry is advantageous.
• Experience in PV with a demonstrable understanding of PV processes and requirements.
• Evidence of being able to build relationships with key internal and external customers and demonstrate customer focus.
• Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities.
• Excellent organizational and prioritization skills strong analytical skills and problem-solving skills.
• Excellent oral and written communication skills.
• Computer literate with good knowledge of MS applications.
• Experience at working both independently and in a team-oriented environment.
• Expertly composes documents that present information or a plan.
• Attention to detail and accuracy.
• Ability to meet deadlines.
• Proactive, diplomatic, self-motivating and professional

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