Global Director, Drug Safety & Pharmacovigilance - Remote

i‑Pharm Consulting; Massachusetts; Remote; USD 180,000 - 240,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Leadership

Signal detection

PV regulations

Regulatory liaison

Cross-functional collaboration

Team management

Education

MD or PharmD

Job description

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.