Associate Director, Pharmacovigilance

Pharmaron • ,

2d • Remote

About The Position

Pharmaron is seeking an experienced Associate Director, Pharmacovigilance to establish and lead its U.S. pharmacovigilance operations. As the first dedicated Pharmacovigilance hire in the United States, this person will help shape the company’s U.S. drug safety services by developing operational processes, leading client-facing programs, collaborating with global teams, and supporting the growth of a U.S.-based pharmacovigilance team.

The role combines technical expertise, operational leadership, and strategic problem-solving in a growing global CRO environment. It includes establishing U.S. operating structures and workflows, independently managing pharmacovigilance projects and client relationships, providing technical and regulatory oversight for clinical-trial and post-marketing safety activities, and contributing to business development and continuous improvement.

Requirements

• Bachelor’s degree or higher in Pharmacy, Medicine, Nursing, Life Sciences, or a related scientific or healthcare discipline.
• At least 8 years of progressive experience in pharmacovigilance or drug safety, including substantial experience supporting clinical development programs.
• Strong working knowledge of FDA pharmacovigilance regulations, ICH guidance, and applicable global safety reporting requirements.
• Demonstrated experience independently managing pharmacovigilance projects, including client communication, operational oversight, and quality management.
• Hands-on understanding of safety case processing, regulatory reporting, aggregate safety reports, and pharmacovigilance quality processes.
• Experience developing or implementing PV processes, SOPs, or operational workflows.
• Strong communication, organizational, and problem-solving skills, with the ability to manage competing priorities and collaborate across international teams.
• Ability to work independently in an evolving environment while balancing strategic priorities with hands-on operational responsibilities.

Nice To Haves

• Previous pharmacovigilance experience within a CRO environment.
• Experience establishing, expanding, or leading a pharmacovigilance team or function.
• Experience managing global or multicenter clinical trial safety programs.
• Familiarity with both clinical trial and post-marketing pharmacovigilance services.
• Experience collaborating with internationally distributed teams, particularly across the United States and China.
• Experience supporting business development activities, client proposals, or technical presentations.
• Mandarin language proficiency.

Responsibilities

• Establish Pharmaron’s U.S. pharmacovigilance function, including its operational structure, processes, and capabilities.
• Partner with global PV leadership and China-based teams to align procedures, quality standards, and service delivery with U.S. regulatory requirements and client expectations.
• Develop, implement, and maintain U.S.-relevant standard operating procedures, Safety Management Plans, and operational workflows.
• Support workforce planning, recruitment, and team development as the U.S. PV function expands.
• Independently manage pharmacovigilance projects, overseeing timelines, deliverables, quality, and regulatory compliance.
• Serve as a primary point of contact for U.S. clients; lead project discussions, communicate progress, and resolve operational challenges.
• Develop study-specific Safety Management Plans and ensure their execution throughout project lifecycles.
• Identify and proactively address operational risks while maintaining client relationships.
• Partner with Clinical Operations, Medical Safety, Data Management, and other cross-functional teams to coordinate safety oversight.
• Oversee pharmacovigilance activities supporting clinical trials and post-marketing safety programs.
• Provide operational and quality oversight of ICSR processing, safety database activities, follow-up, and regulatory reporting.
• Ensure safety reporting meets applicable FDA requirements, ICH guidance, and relevant global regulatory standards.
• Lead or oversee preparation and quality review of aggregate safety reports, including DSURs and PSURs.
• Oversee literature surveillance and support safety signal detection.
• Review deliverables and collaborate with global operational teams to maintain consistent quality and regulatory compliance.
• Act as a pharmacovigilance subject matter expert in client meetings, business development discussions, and proposal activities.
• Contribute technical expertise to project feasibility assessments, bids, and client presentations.
• Collaborate with Business Development to identify opportunities to expand U.S. pharmacovigilance services.
• Identify opportunities to improve operational efficiency, service quality, and cross-functional collaboration.

Benefits

• Comprehensive medical, dental, and vision insurance with significant employer contributions.
• 401(k) retirement plan with generous employer matching.
• Generous paid time off, paid sick leave, and company holidays.
• Employer-funded Health Savings Account contributions for eligible plans, plus healthcare and dependent care Flexible Spending Accounts.
• 100% employer-paid employee life insurance, AD&D, and short- and long-term disability insurance.
• Employee Assistance Program, mental health resources, and wellness programs.
• Family-friendly benefits, including fertility support and maternity resources.
• Professional development and career growth opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director