Director, Medical Safety Assessment Physician, Neuroscience

Bristol Myers Squibb; Lawrence Township (NJ); On-site; USD 255,860 - 347,244; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

401(k) plan

Job summary

Bristol Myers Squibb is seeking a Safety Lead to oversee safety activities and benefit-risk strategies for products in development. You will manage safety signals and ensure compliance with regulatory requirements.

The ideal candidate will have a medical degree, a strong background in pharmacovigilance, and excellent communication skills. The position includes comprehensive benefits and a competitive compensation package.

Qualifications

• 3+ years in pharmacovigilance or relevant pharmaceutical/biomedical fields is preferred.
• Ability to evaluate safety concerns and minimize patient risk.

Responsibilities

• Lead safety activities and benefit-risk strategies for assigned compounds.
• Oversee aggregate safety review documents and regulatory filings.
• Provide medical safety and benefit-risk input for safety reports.

Skills

Understanding of drug development process

Knowledge of pharmacovigilance

Strong analytical reasoning skills

Excellent verbal and written communication skills

Education

MD or equivalent

Postgraduate qualification in psychiatry or neurology

Job description

Position Summary

• Lead safety activities and benefit-risk strategies for assigned BMS compounds/program and chair the product Safety Management Team(s).
• Oversee, prepare and/or review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
• Lead team in the evaluation and management of safety signals emerging from any data source; develop strategy for signal evaluation and document outcome.
• Lead safety labeling activities for assigned products/program and act as the Safety Subject Matter Expert for regulatory product labeling.
• Assist the MSA Therapeutic Area (TA) Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and PS.
• Support the EU Qualified Person for Pharmacovigilance (PV) or other regional Qualified Person for PV relative to issues relating to assigned products.
• Provide input to R&D publication strategy/plan and ensure safety input to publications and presentations.
• Actively drive safety strategy preparation and represent PS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.
• Ensure tasks are performed efficiently, with quality, accuracy, and timeliness in accordance with regulatory requirements and BMS cost‑effectiveness goals.
• Promote collegiality and teamwork among peers; mentor and support colleagues as a positive change agent.

Duties & Responsibilities

General Product Support

• Lead safety activities and benefit-risk strategies for assigned BMS compounds and chair the product SMT(s).
• Oversee, prepare and/or review aggregate safety review documents (e.g., Development Safety Update Reports, Periodic Benefit‑Risk Evaluation Reports) and safety sections of relevant clinical trial documents and regulatory filings.
• Lead team in evaluation & management of signals emerging from any data source; document by Safety Topic Review or Signal Report.
• Lead safety labeling activities for assigned products; support regulatory product labeling and provide regional safety labeling support.
• Support the EU QPPV or other regional Qualified Person for PV relative to assigned products.
• Support R&D publication strategy/plan and ensure safety input to publications and presentations.

Clinical Development

• Act as the global safety lead for assigned compounds in development.
• Provide safety lead support for global submission document production.
• Lead medical safety development and execution of benefit‑risk management strategies for assigned products.
• Provide safety input to clinical development plans, study protocols, amendments, investigator brochures, statistical analysis plan, informed consent forms, clinical study reports, and responses to HA or IRB/EC queries.
• Lead development of safety risk language, risk management strategy, pre‑filing safety activities, integrated safety data review, and 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.

Postmarketing Support

• Act as the safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions.
• Provide medical safety and benefit‑risk input for safety aggregate reports, product renewal submissions, postmarketing study documents and reports, and responses to HA queries.
• Lead medical safety oversight and execution of risk management strategies and RMP elements for assigned products.
• Lead safety signal evaluation and management; prepare and review reports on safety signals and ad‑hoc regulatory responses.
• Provide postmarketing safety study guidance to other groups, including epidemiology and medical affairs.
• Ensure safety labeling adequately reflects emerging postmarketing safety profile.

Department Activities

• Lead process improvement projects.
• Assist in preparing for regulatory inspections, evaluating current processes, and assessing alignment with regulatory expectations.
• Assist the team and senior management in all forms of issue management and crisis management.
• Liaise with all TA staff and maintain an effective, collaborative patient safety team.
• Support hiring and orientation.

Cross‑Functional Activities

• Provide input to strategic plans for safety differentiation of BMS products.
• Prepare and deliver training to BMS employees on product safety profiles.
• Act as PS liaison for assigned products with BMS functions (Legal, BD, Operations, Marketing, etc.).
• Support manufacturing quality; co‑author integrated health hazard assessments.
• Develop communications of safety data and interpretation to BMS and external parties globally.

Qualifications

Education / Experience / Licenses / Certifications

• MD/equivalent required. Postgraduate qualification or experience in psychiatry or neurology preferred. Other relevant experiences and accomplishments considered.
• 3+ years in PV or relevant pharmaceutical or biomedical field (e.g., medical, clinical, regulatory) strongly preferred.

Specific Knowledge, Skills, Abilities

• Understanding of the drug development process.
• Knowledge of PV and ability to apply knowledge to evaluate safety concerns and minimize patient risk throughout the life cycle.
• Proficient in leveraging tools to investigate safety concerns, including observational research.
• Understanding of regulatory requirements for safety assessment and action.
• Strong scientific analytical reasoning skills.
• Ability to work on multiple projects in parallel.
• Excellent attention to detail.
• Behavioral competencies for working and leading within a complex matrix environment.
• Excellent verbal and written communication skills.

Compensation Overview

Cambridge Crossing: $286,560 - $347,244 Madison - Giralda - NJ - US: $255,860 - $310,040 Princeton - NJ - US: $255,860 - $310,040

The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities may be available based on eligibility. Final individual compensation is decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well‑Being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Legal & Compliance Statements

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.

We will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

We will never request payments, financial information, or social security numbers during our application or recruitment process. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.