Director, Drug Safety and Pharmacovigilance

i‑Pharm Consulting; Massachusetts; Remote; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

i‑Pharm Consulting is seeking a Director of Drug Safety and Pharmacovigilance (Remote/East Coast Preferred) to provide strategic pharmacovigilance leadership across late-stage development and commercial programs.

The role emphasizes leading signal detection, safety surveillance, aggregation reporting (DSURs/PSURs/PBRERs/PADERs), and risk management strategies while partnering with Clinical Development, Regulatory Affairs and Medical Affairs on regulatory submissions.

Qualifikationen

• 6+ years in Drug Safety/Pharmacovigilance.
• MD or PharmD strongly preferred.
• Extensive late-stage clinical development safety experience (required).
• Proven signal detection and safety surveillance expertise (required).
• Deep knowledge of global PV regulations and compliance requirements (required).
• Experience supporting major regulatory filings and health authority interactions (NDA, sNDA, MAA).
• Strong aggregate safety reporting and benefit-risk assessment experience.

Aufgaben

• Lead signal detection and safety surveillance activities across late-stage programs.
• Author/oversee DSURs, PSURs/PBRERs, PADERs, and IND annual reports.
• Drive benefit-risk assessments and risk management strategies.
• Support global regulatory submissions and health authority interactions, partnering cross-functionally with Clinical Development, Regulatory Affairs and Medical Affairs.

Kenntnisse

Leadership

Signal detection

PV regulations

Regulatory liaison

Cross-functional collaboration

Team management

Ausbildung

MD or PharmD

Jobbeschreibung

Director, Drug Safety and Pharmacovigilance (Remote/East Coast Preferred)

Full-time

Remote

Seeking an experienced Global DSPV Leader (MD or PharmD preferred) to provide strategic pharmacovigilance leadership across late-stage clinical development and commercial programs.

Key responsibilities include leading signal detection and safety surveillance activities, authoring and overseeing aggregate safety reports (DSURs, PSURs/PBRERs, PADERs, IND annual reports), driving benefit-risk assessments and risk management strategies, and supporting global regulatory submissions and health authority interactions.

The ideal candidate will have deep expertise in global pharmacovigilance regulations, safety risk management, aggregate reporting, and regulatory filings (NDA, sNDA, MAA). Strong experience supporting late-stage clinical development programs is required, along with the ability to partner cross-functionally with Clinical Development, Regulatory Affairs, and Medical Affairs teams.

Required Experience:

• 6+ years in Drug Safety/Pharmacovigilance
• MD or PharmD strongly preferred
• Extensive late-stage clinical development safety experience (required)
• Proven signal detection and safety surveillance expertise (required)
• Deep knowledge of global PV regulations and compliance requirements (required)
• Experience supporting major regulatory filings and health authority interactions (NDA, sNDA, MAA)
• Strong aggregate safety reporting and benefit-risk assessment experience
• Experience with both development and post-marketing safety activities preferred