Vice President, Drug Safety & Risk Management - REMOTE - IMMEDIATE NEED

Implaion Recruiting; United States; À distance; USD 330 000 - 442 800; Plein temps

Résumé du poste

A leading recruitment agency is seeking a Vice President of Drug Safety & Pharmacovigilance to oversee patient safety strategy and regulatory compliance in a dynamic, remote environment. This executive will lead the pharmacovigilance efforts across therapeutic areas, ensuring adherence to regulatory standards while managing a high-performing team. The ideal candidate will possess extensive experience in the field and a strong background in biotech leadership.

Qualifications

• 10+ years in pharmacovigilance and drug safety, including biotech leadership.
• Experience with global safety reporting and commercial PV systems.
• Familiar with 21 CFR 312.32, 314.80.

Responsabilités

• Lead global safety and pharmacovigilance across development programs.
• Ensure global PV compliance and readiness for inspections/audits.
• Drive benefit-risk assessments and liaise with regulatory authorities.

Connaissances

Pharmacovigilance

Signal Detection

Risk Management

Regulatory Compliance

Leadership

Formation

MD or equivalent

Outils

Argus

Description du poste

Vice President, Drug Safety & Pharmacovigilance - REMOTE - IMMEDIATE NEED

Vice President, Drug Safety & Pharmacovigilance - REMOTE - IMMEDIATE NEED

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Vice President, Drug Safety & Pharmacovigilance

• Location: REMOTE
• Seniority Level: Executive
• Employment Type: Full-time

About the Role

We’re looking for a seasoned executive to lead global safety and pharmacovigilance (PV) across all development programs. This role is accountable for patient safety strategy, regulatory compliance, and signal management, from early-stage development through commercialization. You’ll work cross-functionally with Clinical, Regulatory, Medical Affairs, Quality, and external partners.

Key Responsibilities

• Own and lead PV strategy across the entire therapeutic portfolio
• Collaborate cross-functionally to align safety data, risk management, and communication
• Drive benefit-risk assessments and interface directly with regulatory authorities
• Lead signal detection using clinical, real-world, and market data
• Ensure global PV compliance and readiness for inspections/audits
• Oversee vendor relationships and safety database (e.g., Argus) management
• Submit DSURs, PSURs/PBRERs, and other safety reports to regulatory bodies
• Build and lead a high-performing internal safety team

What We’re Looking For

• MD (or equivalent) required
• 10+ years in pharmacovigilance and drug safety, including biotech leadership
• Working in a small company environment (<100 staff) required
• Experience with global safety reporting, outsourced data, and commercial PV systems
• Expert in MedDRA (SMQs, FMQs, PTs) and signal detection methodologies
• Familiar with 21 CFR 312.32, 314.80, and BIMO inspection prep
• Skilled in regulatory engagement, negotiation, and issue resolution
• Practical, risk-based decision maker with a bias for action
• Proven leader who can manage internal teams and external vendors with urgency and ownership

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Executive Search Services

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