Director, Patient Safety Scientist
Bristol Myers Squibb
15 days ago
Remote friendly (Madison, NJ)
United States
Medical Affairs
Position Summary:
The Director, Patient Safety Scientist is a key partner and strategic advisor to the Medical Safety Assessment Physician (MSAP)/Safety Management Team (SMT) Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence to influence decision-making. Independently performs core signal detection, elevates program/portfolio issues, leads safety data review meetings (SDRMs), and ensures pharmacovigilance regulatory compliance.
Position Responsibilities:
- Develop/co-develop global safety strategy with the SMT Chair; oversee signal detection and assessment across the product lifecycle.
- Lead signal evaluation activities (case-series, literature review, health authority/claims databases); collaborate on signal reports; ensure tracking, stakeholder engagement, and documentation in the signal management system.
- Provide medical writing support for safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER).
- Develop strategies, analyze data, and author ad hoc health authority responses; support local market risk-management queries; mentor less experienced scientists.
- Lead preparation/review of safety sections for clinical trial documents (protocols, CSRs, IBs/RSI, ICFs, contraception language).
- Represent Patient Safety and support safety strategy preparation at internal/external meetings.
- Co-develop safety strategy and regulatory filing input; author safety sections for MAAs and support ad hoc regulatory safety updates (e.g., 120-day updates).
- Analyze data and author documentation for postmarketing safety labeling updates; support EU QPPV/other regional/local QP.
- Create/update EDSR strategy; support Structured Benefit Risk and alignment on Company Core Risk Management; collaborate on risk minimization effectiveness and PASS NIR.
- Lead global/EU Risk Management Plans (RMPs); account for in-licensing/pharmacovigilance agreements impacting risk management.
- Lead creation/revisions to additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs); guide local markets and vendors.
Degree & Experience Requirements:
- Scientific degree (BS, MS, RN, PharmD, PhD, MD) or equivalent education/experience.
- Minimum 8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; ability to mentor and coach.
Key Competencies:
- Ability to develop/execute safety strategy across complex cross-functional initiatives.
- Deep scientific/medical expertise to synthesize clinical, nonclinical, postmarketing, and literature data.
- Strong decision-making with scientific rigor.
- Matrix leadership with strong organizational, facilitation, and communication skills.
- Adaptable/resilient; initiative and professionalism.
- Ability to incorporate emerging technologies (AI, automation, digital platforms) while maintaining rigor/compliance.
The Director, Patient Safety Scientist is a key partner and strategic advisor to the Medical Safety Assessment Physician (MSAP)/Safety Management Team (SMT) Chair to characterize conditions for safe use of BMS medicines and proactively communicate safety evidence to influence decision-making. Independently performs core signal detection, elevates program/portfolio issues, leads safety data review meetings (SDRMs), and ensures pharmacovigilance regulatory compliance.
Position Responsibilities:
- Develop/co-develop global safety strategy with the SMT Chair; oversee signal detection and assessment across the product lifecycle.
- Lead signal evaluation activities (case-series, literature review, health authority/claims databases); collaborate on signal reports; ensure tracking, stakeholder engagement, and documentation in the signal management system.
- Provide medical writing support for safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER).
- Develop strategies, analyze data, and author ad hoc health authority responses; support local market risk-management queries; mentor less experienced scientists.
- Lead preparation/review of safety sections for clinical trial documents (protocols, CSRs, IBs/RSI, ICFs, contraception language).
- Represent Patient Safety and support safety strategy preparation at internal/external meetings.
- Co-develop safety strategy and regulatory filing input; author safety sections for MAAs and support ad hoc regulatory safety updates (e.g., 120-day updates).
- Analyze data and author documentation for postmarketing safety labeling updates; support EU QPPV/other regional/local QP.
- Create/update EDSR strategy; support Structured Benefit Risk and alignment on Company Core Risk Management; collaborate on risk minimization effectiveness and PASS NIR.
- Lead global/EU Risk Management Plans (RMPs); account for in-licensing/pharmacovigilance agreements impacting risk management.
- Lead creation/revisions to additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs); guide local markets and vendors.
Degree & Experience Requirements:
- Scientific degree (BS, MS, RN, PharmD, PhD, MD) or equivalent education/experience.
- Minimum 8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; ability to mentor and coach.
Key Competencies:
- Ability to develop/execute safety strategy across complex cross-functional initiatives.
- Deep scientific/medical expertise to synthesize clinical, nonclinical, postmarketing, and literature data.
- Strong decision-making with scientific rigor.
- Matrix leadership with strong organizational, facilitation, and communication skills.
- Adaptable/resilient; initiative and professionalism.
- Ability to incorporate emerging technologies (AI, automation, digital platforms) while maintaining rigor/compliance.