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.

Requirements:

• 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 dominic.pritchard@biotalent.com