Introduction
Our client, a specialist in the pharmaceutical industry, is currently recruiting a Pharmacovigilance Physician for their Centurion Office.
Purpose of the Job:
This role will play a key role in bringing deep clinical understanding and judgment in benefit-risk assessments for the Company and Client’s products. This role will support the medical components of Pharmacovigilance (PV) for the Company and their Client’s projects. This role will also ensure projects adhere to Good Clinical and Pharmacovigilance Practice and Regulatory Requirements.
This role requires you to be a passionate pharmacovigilance professional, who is a dedicated and enthusiastic team player, who strives to gain and maintain an exceptional reputation for the Company and its Clients, and who is knowledgeable, cares, and produces high-quality work.
Duties & Responsibilities
Essential functions and responsibilities:
For the Company
- Working cross-functionally with multiple disciplines to provide guidance on productive cross-functional medical safety collaborations for the Company and Clients.
- Support quality and efficiency strategies within the organization.
- Supporting the Business/ Commercial team in PV medical aspects in the development of contracts and proposals.
- Supporting the Company by attending BID defence meetings and conferences as the medical expert, as required.
- Providing Senior Management with 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 PV systems and actively participating in PV inspections or audits.
- The integration, analysis, and interpretation of safety information collected from pre-clinical through to post-marketing, including medical review of individual case safety reports, signal management reports, aggregate reports, and risk/benefit analysis for product portfolio.
- Involvement in the development of Risk Management Planning/ Signal Management Reports/ Periodic Safety Update reports/ Developmental Safety Update Reports and other aggregate/ ad hoc reports for product portfolio.
- Actively participating in the Signalling Meeting, Drug Safety Committee, and Labelling Committee – and providing medical input for benefit/risk analysis for the product throughout the product life cycle.
- Providing medical input for product activities relating to Investigator’s Brochures, Clinical Study Protocol, Study Safety Plans, and Clinical Safety reports.
- Reviewing or drafting responses to requests on all drug safety matters from Regulatory Authorities for product portfolio.
- Support the collation and dissemination of quality and compliance metrics for PV and medical information activities.
- Support the growth of new PV business, as required.
2. For the Clients
- The integration, analysis, and interpretation of safety information collected from pre-clinical through to post-marketing, including medical review of individual case safety reports, signal management reports, aggregate reports, and risk/benefit analysis.
- Providing expert safety input to the clinical development program for some Client projects while giving expert medical input to clinical trials.
- Maintaining good Client relations and ensuring a consistently high quality of work for each Client.
- Attending regular Client meetings to present/discuss safety data received/reviewed.
- Advising the Client as requested or as appropriate in PV matters such as changes in regulations/guidance.
- Participation in Client audits and inspections.
- Ensuring Compliance with PV regulatory obligations; managing the process for root cause analysis and implementing corrective and preventative actions (CAPAs), as required.
- Ensuring that Investigator’s Brochures, Clinical Study Protocols, and Study Safety Plans/ Client Operating Procedures include a formal check of all areas related to PV Physician-related activities as outlined in the Client contract.
- Reviewing or drafting responses to requests on all drug safety matters from Regulatory Authorities.
- Involvement in the development of Risk Management Plans/ Periodic Safety Update reports/ Developmental Safety Update Reports and other aggregate/ ad hoc reports for Client products.
- Actively participating in the Drug Safety Committee – signal detection and risk evaluation process for Client medicinal products in the product’s life cycle.
Desired Experience & Qualification
- The PV Physician should be medically qualified as a physician; ideally a higher qualification also or a postgraduate qualification relevant to PV or pharmacoepidemiology.
- Extensive experience of PV in the Pharmaceutical Industry, with focus on signal detection, aggregate report writing and risk management.
- Experience of orphan drug/rare diseases/biologics preferred.
- Understanding of international PV requirements and drug development and approval regulatory processes as they pertain to the role.
- Knowledge of pharmacoepidemiology pertinent to drug utilisation and safety preferred.
- Experience in clinical research and/or PV is preferred.
- Experience with leading or supporting the proactive monitoring and evaluation of all aspects of the safety profile of designated products and ensuring that optimal decisions are made, relating to signal detection activities, safety signal evaluations, updates to product labeling documents, responses to regulatory agency inquiries, and product quality issues.
- Experience in reviewing different aggregate report types including PADERs, PBRERs, DSURs, Annual Safety reports, and RMPs is mandatory.
- Prior experience in supporting business development activities and bid defence meetings.
- Previous experience with authoring/reviewing PV procedures is preferred.
- Experience with PV processes and global PV regulations.
- Ability to present complex data/information at all levels of the organisation and externally.
- Good decision-making and problem-resolution based on all relevant information.
- Analytical thinking, with proven ability to lead analysis of safety data whilst applying sound medical judgment.
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