Senior Medical Director, Drug Safety and Pharmacovigilance

Posted 09 May 2023
Job type Permanent
Contact NameDominic Pritchard

Job description

BioTalent is partnered with a well know Global BioTech to appoint a Senior Medical Director of Safety and Pharmacovigilance. Due to accelerated developments and pipeline a senior leader is required who has expertise weighted towards post-marketing. (Overall pipeline responsibility will still include clinical). Ideally suited would be someone with success in MAA and NDA from a Safety/PV perspective.

Responsibilities not limited to:
  • Contribution to safety sections of key documents (e.g. protocols, ICFs, IBs, RMPs, CDS, labels, INDs).
  • Coordination and project management of aggregate safety reports (e.g. PSURs/PBRERs, PADERs). 
  • Risk management activities, including risk strategies for assets in all phases of development and life-cycle
  • Signal detection, signal investigation and assessment, literature review, proactive management of the benefit-risk profile for assigned products and any resultant activities such as revisions to core safety information.
  • Medical degree and experience in patient facing role 
  • 10+ years industry experience in Safety/Pharmacovigilance with expertise in post-marketing (alignment to oncology would be a bonus) 
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders
  • Strong understanding of pharmacovigilance regulations and international regulations governing drug safety (US and EU) for pre and post-marketing.
  • Demonstrated leadership (matrix management) and collaborative skills 
If this role is for you then reach out to