Pharmacovigilance Head

Barrington James; United States; Remote; USD 130,000 - 160,000; Part time

Job summary

A leading consultancy is seeking a part-time Pharmacovigilance Head to develop and oversee drug safety strategies. This remote role requires a strong background in managing regulatory interactions and coordinating with health authorities, along with leading safety teams to ensure compliance across various departments in pharmaceuticals.

Qualifications

• Managed interactions with the FDA.
• Experience in establishing and running pharmacovigilance departments.
• Strong understanding of regulatory compliance.

Responsibilities

• Lead drug safety and pharmacovigilance strategy.
• Oversee safety reports and actions.
• Manage relationships with PV vendors.

Skills

Leadership

Regulatory Compliance

Drug Safety Strategy

Job description

1 month ago Be among the first 25 applicants

Barrington James is partnered with a large research consultancy looking to bring on board a Pharmacovigilance Head on a part time contract.

Responsibilities would include:

• Lead the company’s drug safety and pharmacovigilance strategy.
• Oversee collection, evaluation, and reporting of side effects (adverse events).
• Manage safety reports (e.g., PSURs, DSURs, RMPs) for health authorities like FDA and EMA.
• Detect and assess safety signals and take action if needed.
• Work with other departments (Clinical, Regulatory, Medical, Quality) on product safety.
• Lead safety-related meetings and decision-making groups.
• Manage relationships with PV vendors and ensure high-quality work.
• Prepare for and lead regulatory inspections and audits.
• Build and lead a strong PV team

Requirements:

• Must have managed FDA interactions
• Familiar with setting up and running PV departments
• Experience in ensuring regulatory compliance

This is a fully remote position but candidates would need to be based in the US

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Contract

Job function

• Job function

  Science, Consulting, and Research

• Industries

  Pharmaceutical Manufacturing, Research Services, and Biotechnology Research

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