Senior Manager Safety PV Ops
Bristol Myers Squibb
11 hours ago
Remote friendly (Princeton, NJ)
United States
Operations
Summary/Job Purpose
- Provide management oversight of Global Patient Safety case management, operational oversight of drug safety case management vendors, safety submission compliance, and cross-functional collaboration to support risk management and pharmacovigilance.
Responsibilities
- Lead global ICSR activities to comply with global ICSR regulations.
- Manage PV operations program(s) from study start-up preparations through closure with stakeholders.
- Oversee vendor processes, training, and compliance; support CAPA development.
- Ensure safety submission compliance with business partners, CROs, and global regulatory authorities.
- Support inspection readiness/during inspections.
- Support data outputs/requests for information.
- Ensure data reconciliation of safety and clinical databases for Serious Adverse Events.
- Use metrics for productivity, workflow/quality improvement, and change effectiveness.
- Support aggregate reporting readiness (e.g., DSUR, IDMC listings) and alignment with case management, aggregate reporting, and signal detection.
- Collaborate on safety-related study documents (e.g., protocols, ICFs, Safety Management Plans, PVA/SDEA, DMP, ECCG plan, SAE Recon Plan, DTA Plan, Monthly Data Review).
- Partner with Quality to develop/update integrated PV and Safety SOPs/Work Instructions.
Qualifications/Skills
- BS/BA in related discipline plus 10+ years related experience (or equivalent).
- 8+ years in Pharmacovigilance Operations (drug safety PV).
- Knowledge of international adverse event reporting requirements.
- Proven experience guiding PV vendor staff.
- Deep knowledge of US and international regulations for clinical trial and post-marketing safety.
- Strong communication, organization, collaboration, and problem-solving skills; ability to train/mentor.
Benefits (as stated)
- Health coverage (medical/pharmacy/dental/vision); 401(k); short- and long-term disability; life/accident insurance; Paid Time Off (flexible time off for US exempt; specified vacation/holidays for other groups).
- Provide management oversight of Global Patient Safety case management, operational oversight of drug safety case management vendors, safety submission compliance, and cross-functional collaboration to support risk management and pharmacovigilance.
Responsibilities
- Lead global ICSR activities to comply with global ICSR regulations.
- Manage PV operations program(s) from study start-up preparations through closure with stakeholders.
- Oversee vendor processes, training, and compliance; support CAPA development.
- Ensure safety submission compliance with business partners, CROs, and global regulatory authorities.
- Support inspection readiness/during inspections.
- Support data outputs/requests for information.
- Ensure data reconciliation of safety and clinical databases for Serious Adverse Events.
- Use metrics for productivity, workflow/quality improvement, and change effectiveness.
- Support aggregate reporting readiness (e.g., DSUR, IDMC listings) and alignment with case management, aggregate reporting, and signal detection.
- Collaborate on safety-related study documents (e.g., protocols, ICFs, Safety Management Plans, PVA/SDEA, DMP, ECCG plan, SAE Recon Plan, DTA Plan, Monthly Data Review).
- Partner with Quality to develop/update integrated PV and Safety SOPs/Work Instructions.
Qualifications/Skills
- BS/BA in related discipline plus 10+ years related experience (or equivalent).
- 8+ years in Pharmacovigilance Operations (drug safety PV).
- Knowledge of international adverse event reporting requirements.
- Proven experience guiding PV vendor staff.
- Deep knowledge of US and international regulations for clinical trial and post-marketing safety.
- Strong communication, organization, collaboration, and problem-solving skills; ability to train/mentor.
Benefits (as stated)
- Health coverage (medical/pharmacy/dental/vision); 401(k); short- and long-term disability; life/accident insurance; Paid Time Off (flexible time off for US exempt; specified vacation/holidays for other groups).