Lead the global Medical Safety strategy for assigned company’s product
Ensure timely delivery of safety contributions to support clinical development strategies
Lead cross functional safety surveillance activities as a product GSL and chair of the SRMT
Develop a strong working relationship with the three other pillars of pharmacovigilance
Foster a culture that promotes a shared company-wide responsibility for “Patient Safety First”
Ensure that safety data from non-clinical studies are reviewed and considered
Support NDA submission and communications to Regulatory Agencies for assigned Company’s product
Ensure timely submission of all safety reports to worldwide health authorities
Provide guidance for safety sections of clinical study documents
Identify key medical safety issues, trends, and proactive develop effective mitigation strategies
Collaborate with Clinical Development and Medical Affairs to develop publications

Medical degree (MD) required
At least 5 years’ experience in clinical/medical practice preferred
Minimum of 7 years’ experience as a safety physician in drug safety & pharmacovigilance
Neuropsychiatry experience is desirable
Experience authoring and overseeing safety signal assessment report, DSUR, PBRER, RMP/REMS, and RSI
Experience in all phases of global drug development process from pre-IND through NDA and post-licensure
Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines
Experience with Argus or ARISg systems, Global Safety Database data mining and MedDRA coding
Excellent interpersonal communication and presentation skills
Time management skills with ability to prioritize meeting required deadlines
Ability to multitask and work under tight deadlines

Medical Director – Drug Safety and Pharmacovigilance

Key skills