Senior Medical Director, Pharmacovigilance – Global Safety

Deciphera Pharmaceuticals; Waltham (MA); Hybrid; USD 292,000 - 403,000; Full time

Benefits offered by this job

Competitive salary & bonus

Comprehensive benefits

Parental leave

Growth opportunities

Job summary

Deciphera Pharmaceuticals is seeking a Senior Medical Director, Pharmacovigilance to lead global pharmacovigilance for marketed and investigational products. The role oversees medical review of cases, signal management, aggregate reports, and regulatory submissions, while guiding cross-functional teams as a medical expert.

The position emphasizes leadership in benefit-risk management, medical review for ICIRs, safety content in study documents, and collaboration with Regulatory Affairs to ensure

Qualifications

• MD from an accredited institution; board certified preferred; board eligible or OUS equivalent.
• 10+ years pharmacovigilance/drug safety experience in pharma/biotech/CRO environments.
• Strong scientific/clinical and analytical background with ability to assess data.
• Proven experience with regulatory submissions (INDs, NDAs, MAAs) and safety reporting.
• Ability to lead cross-functional teams and communicate with regulatory bodies.

Responsibilities

• Lead and oversee safety surveillance, benefit-risk assessment and risk management for assigned products across their life cycle.
• Provide pharmacovigilance expertise for decision making based on risk/benefit, data analysis and interpretation.
• Oversee safety documentation for regulatory submissions (INDs, NDAs, MAAs).
• Attend/lead Safety Committee meetings to drive decisions and next steps.
• Collaborate with Regulatory Affairs and cross-functional teams on safety issues and risk assessments.
• Develop and maintain risk management plans (RMPs) and REMS as applicable.
• Serve as a key member on Product Safety Committee; present safety issues and risk mitigation strategies.
• Review PSUR/DSUR/PADER and other periodic safety reports.

Skills

Pharmacovigilance

Medical review

Risk management

Regulatory submissions

Team leadership

Cross-functional collaboration

Medical writing

Education

MD

Tools

Argus

ARISg

MS Office

Medical coding dictionaries

Job description

Deciphera Pharmaceuticals is seeking a Senior Medical Director, Pharmacovigilance to lead global pharmacovigilance for marketed and investigational products. The role oversees medical review of cases, signal management, aggregate reports, and regulatory submissions, while guiding cross-functional teams as a medical expert.

The position emphasizes leadership in benefit-risk management, medical review for ICIRs, safety content in study documents, and collaboration with Regulatory Affairs to ensure