Pharmaceuticals

Director of Pharmacovigilance

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About the job

Do you have significant leadership/managerial experience within Pharmacovigilance in the Pharmaceutical industry? Are you ready for the next step in your career?

Invenia Group is currently partnered with a world-leading pharmaceutical company focused on the manufacture and distribution of generic drugs. They are looking for a professional to join the team as a Director of Pharmacovigilance and lead the US Pharmacovigilance and Quality Complaint oversight. This is a great opportunity to join a top-performing company and expand your market outreach on a global scale – our client is present in over 125 countries!

Role responsibilities:

If successful, you will be responsible for the oversight and management of Pharmacovigilance vendors to maintain regulatory compliance and contractual obligations. You will also be responsible for the following:

  • Review of safety within quality and compliance documents – protocols, annual reports, investigational brochures, quality agreements etc
  • Review of Safety Management Plans to sustain the success of study-specific and health authority reporting requirements and the define the workflow between CROs and APUSA
  • Development, review and update of drug safety forms and templates
  • Writing, review and approval of Safety Data Exchange Agreements
  • Planning and oversight of SAE database reconciliation alongside Data Management
  • Cross-functional collaboration within the wider PV team, business entity and third-party vendors
  • Lead/support inspections/audits both internally and externally
  • Act as a responsible person for PV for all PV activities in the US

What we are looking for:

We are looking for someone with significant leadership/managerial experience within Pharmacovigilance in the Pharmaceutical industry (8+ years). You should have a great working knowledge of DA, EU, ICH guidelines/initiatives/regulations in the field of Safety reporting and processing for clinical trial environments. Ideally, you should also have an MD, PharmD or RN degree.

Flexibility to travel (25%) is also necessary for this role.

If you are interested in proceeding with this opportunity, please apply to find out more.