Director, Medical Safety Assessment Physician, Neuro - Cambridge C. MA

About the role

The role involves leading safety activities and benefit-risk strategies for assigned BMS compounds/program, chairing the product Safety Management Team(s), overseeing safety review documents, managing safety signals, and supporting various cross-functional teams.

Responsibilities

• Lead safety activities and benefit-risk strategies for assigned BMS compounds and chair the products SMT(s).
• Oversee, prepare and/or review aggregate safety review documents (DSUR, PBRER) and safety sections of relevant clinical trial documents (protocols, CSR, ICF) and regulatory filings (CTA, MAA).
• Lead team in evaluation & management of signals emerging from any data source (case-series, literature review, HA/claims database).
• Document by Safety Topic Review/ Signal Report or other means of communication.
• Lead safety labeling activities for assigned products.
• Support Safety input for regulatory product labeling.
• Participate/ provide input at cross-functional labeling team meetings and provide regional safety labeling support.
• Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
• Support R&D publication strategy/ plan & ensure safety input to publications/ presentations.
• Act as the global safety lead for assigned compounds in development.
• Provide safety lead support for global submission document production.
• Review draft summary documents.
• Provide safety input to clinical development plans, study protocols, amendments, IB, SAP, ICF, CSR, responses to HA or IRB/EC queries.
• Lead development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, safety-focused publication development.
• Perform medical safety review of development update safety reports, annual reports and other periodic safety submissions.
• Support safety strategy preparation for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc.
• Act as the safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions.
• Provide medical safety, benefit-risk input for safety aggregate reports, product renewal submissions, postmarketing study documents and reports, responses to HA queries.
• Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
• Lead safety signal evaluation & management.
• Prepare and review reports on safety signals (Safety Topic Reviews/ Signal Reports) and ad hoc regulatory responses.
• Provide postmarketing safety study guidance to other groups including epidemiology and medical affairs including but not limited to ISR, epidemiology studies, and non-interventional safety studies.
• Ensure safety labeling adequately reflects emerging postmarketing safety profile.

Qualifications

• MD/equivalent required.
• Postgraduate qualification or experience in psychiatry or neurology preferred.
• Relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.
• 3+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred.