Pharmacovigilance Physician - Centurion, South Africa - Profession Hub

Profession Hub
Profession Hub
Verified Company
Centurion, South Africa

1 week ago

Thabo Mthembu

Posted by:

Thabo Mthembu

beBee Recruiter
Description
Our client is searching for a Pharmacovigilance Physician to join their team in Irene Centurion.


Job Profile


This role will play a key role in bringing deep clinical understanding and judgement in benefit-risk assessments for the Organisation and their Client's products.

This role will support the medical components of Pharmacovigilance (PV) for the organisation and their Client's projects. This role will also ensure projects adhere to Good organisational and Pharmacovigilance Practices 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 organisation and their Clients and who is knowledgeable, cares and produces high-quality work.


Key Responsibilities

For the Company

  • Working crossfunctionally with multiple disciplines to guide productive crossfunctional medical safety collaborations for the organisation and Clients.
  • Support quality and efficiency strategies within the organization.
  • Supporting the Organisational Business/ Commercial team in PV medical aspects in the development of contracts and proposals.
  • Supporting the organisation 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 raining presentations and delivering training, as required.
  • Assisting in departmental regulatory inspection preparedness for the Organisation's PV system and actively participating in the PV inspections or audits.
  • The integration, analysis and interpretation of safety information collected from preclinical through to postmarketing, including medical review of individual case safety reports, signal management reports, aggregate reports and risk/benefit analysis for the organisation's 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
the organisation's product portfolio.

  • Actively participating in the Signalling Meeting, Drug Safety Committee, and Labelling Committee and providing medical input for benefit/risk analysis for the organisation's product throughout the product life cycle.
  • Providing medical input for the organisation's 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 the organisation's product portfolio.
  • Support the collation and dissemination of quality and compliance metrics for PV and medical information activities.
  • Develop/ educate employees.
  • Support the growth of new PV business, as required.

For the Clients

  • The integration, analysis and interpretation of safety information collected from preclinical through to postmarketing, 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 Physicianrelated 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.

Requirements:


  • The PV Physician should be medically qualified as a physician; ideally a higher qualification also or a postgraduate qualification relevant to PV or pharmacoepidemiology.
  • 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
More jobs from Profession Hub
See all jobs of Profession Hub