Job Postings: Physician needed with pharma experience for senior director of global safety operations position

Amylin Pharmaceuticals

Senior Director Global Safety Operations

M.D. required. At least 6 years of industry Pharmacovigilance experience. Must have experience analyzing safety data, PSUR writing, US Periodic and ad Hoc safety reports, risk management documents, etc. Must possess excellent clinical and critical analytical skills with a keen understanding of clinical safety analysis. Candidate must have previously demonstrated solid collaboration and leadership capacity with safety- benefit/risk analysis and related communications with senior management and other key stakeholders.


Resopnsibilities:

The primary responsibilities of this position are to provide Pharmacovigilance expertise to ensure that potential safety issues are identified early, its significance/impact analyzed, and effectively communicated to appropriate members. Proactively identify potential safety signals from marketed products globally. Clinically evaluate aggregate safety data and individual spontaneous reports per applicable regulations for potential safety signals and where necessary develop strategies to enable further assessment of safety signals. Develop risk management strategies, prepare and maintain risk management plans including proposed changes to product labeling. Advise on additional activities to minimize product safety risks. Provide medical input in periodic reporting documents (PSR/PSURs, etc), core data sheets, risk management plan. Prepare responses to regulatory agency inquiries regarding product safely, benefit-risk assessment and risk management.

Please contact for additional information:

Kellie Woodworth
Senior Executive Recruitment
Direct: (562) 430-3763
Cell: (818) 299-7200