Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience

About the role

The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements.

Responsibilities

• Provide strategic oversight & delivery of medical safety assessment for assets in therapeutic area (TA) by effective management of safety physician team.
• Oversee safety activities and benefit-risk strategies for assigned compound(s)/ program(s) and chair the product/TA Safety Management Team (SMT).
• Oversee, Review, and Approve aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
• Oversee team in evaluation & management of signals emerging from any data source. Guide strategy for signal evaluation (eg, case-series, literature review, HA/ claims database).
• Ensure documentation by Safety Topic Review/Signal Report or other means of communication. Approve safety labeling activities for assigned products.
• Provide Safety Subject Matter Expertise for input to regulatory product labeling.
• Drive change in the organization and adoption of new processes.
• Assist the MSA TA Head in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS.
• Identify data gaps and Prioritize data acquisition. Provide input to strategic plans for safety differentiation of BMS products.
• Oversee and/or provide training to BMS employees on product safety profiles/issues.
• Provide input to due diligence and potential in-licensing opportunities as requested.
• Act as WWPS TA liaison for assigned products with BMS functions (Legal, BD, Operations, Marketing, etc.).
• Support manufacturing quality. Review integrated health hazard assessments. Review communications of safety data & interpretation to BMS and external parties, globally.

Qualifications

• MD/equivalent required.
• Postgraduate qualification or experience in internal medicine, immunology, oncology, or related specialty desirable.
• 7+ years in pharmacovigilance (PV) or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred.
• Management experience is strongly preferred.
• Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.

Skills

• Extensive understanding of the drug development process.
• Expert knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
• Skilled ability to direct (and leverage) range of available tools to investigate safety concerns, including the science of observational research.
• In-depth understanding of regulatory requirements for safety assessment and action.
• Expert scientific analytical reasoning skills.
• Skilled ability to manage (and work on) multiple complex projects in parallel.
• Excellent attention to detail.
• Behavioral competencies necessary to work and lead within a complex matrix environment.
• Excellent verbal and written communication skills.

Benefits

Read more careers.bms.com/working-with-us.

Pay

$334,860 - $405,769

Schedule

Occasional travel within the US (eg, once every 2-3 months) and overseas (eg, once a year)