Lead Patient Safety Scientist — Signal, Risk & Strategy

Bristol-Myers Squibb Co; Madison (NJ); Sur place; USD 150 000 - 182 000; Plein temps

Avantages offerts par ce poste

Flexible Time Off

Paid holidays

Health insurance

Résumé du poste

Bristol-Myers Squibb Co. is seeking a senior Pharmacovigilance leader to partner with the Medical Safety Assessment Physician and Safety Management Team Chair to define conditions for safe use of medicines and proactively communicate safety evidence.

You will independently perform core signal detection activities, lead SDRMs, and ensure pharmacovigilance regulatory compliance across development and marketed products.

Qualifications

• Scientific degree or equivalent in life sciences
• 6-8 years pharmacovigilance/pharma industry experience
• Ability to mentor others and lead safety strategies
• Strong communication and organizational skills
• Experience with safety documentation and regulatory interactions

Responsabilités

• Lead signal detection activities and SDRMs with SMT Chair.
• Prepare safety sections for protocols, CSR, IB, and labeling.
• Drive regulatory safety strategy for filings and postmarketing.
• Develop and manage global RMPs and aRMMs.
• Integrate AI/data platforms to optimize safety workflows.
• Support inspections and audits.

Connaissances

Signal detection

Safety surveillance

Medical writing

Data analysis

Regulatory knowledge

Cross-functional collaboration

Formation

Scientific degree (BS/MS/PharmD/PhD/MD)

Outils

Signal management system

Description du poste

Bristol-Myers Squibb Co. is seeking a senior Pharmacovigilance leader to partner with the Medical Safety Assessment Physician and Safety Management Team Chair to define conditions for safe use of medicines and proactively communicate safety evidence.

You will independently perform core signal detection activities, lead SDRMs, and ensure pharmacovigilance regulatory compliance across development and marketed products.