[Hiring] Associate Director, Pharmacovigilance @Pharmaron

Role Description

Pharmaron is seeking an experienced Associate Director, Pharmacovigilance to establish and lead our U.S. pharmacovigilance operations. As our first dedicated Pharmacovigilance hire in the United States, you will play a key role in shaping the future of our U.S. drug safety services. You'll help establish operational processes, lead client-facing PV programs, collaborate with our established global teams, and support the development of a U.S.-based pharmacovigilance team. This is an opportunity for an experienced PV professional who enjoys combining technical expertise, operational leadership, and strategic problem-solving in a growing global CRO environment.

Key Responsibilities

• Establish and Grow U.S. Pharmacovigilance Operations
  • Serve as a key leader in establishing Pharmaron's U.S. pharmacovigilance function, helping develop the operational structure, processes, and capabilities needed to support our growing client base.
  • Partner with global PV leadership and China-based teams to align operating procedures, quality standards, and service delivery with U.S. regulatory requirements and client expectations.
  • Develop, implement, and maintain U.S.-relevant standard operating procedures (SOPs), Safety Management Plans, and operational workflows.
  • Support workforce planning, recruitment, and team development as the U.S. PV function expands.
• Lead Pharmacovigilance Programs and Client Relationships
  • Independently manage pharmacovigilance projects, overseeing timelines, deliverables, quality, and regulatory compliance.
  • Serve as a primary point of contact for U.S. clients, leading project discussions, communicating progress, and resolving operational challenges.
  • Develop study-specific Safety Management Plans and ensure appropriate execution throughout the project lifecycle.
  • Identify and proactively address operational risks while maintaining strong client relationships.
  • Partner with Clinical Operations, Medical Safety, Data Management, and other cross-functional teams to ensure coordinated safety oversight.
• Provide Technical and Regulatory Oversight
  • Oversee pharmacovigilance activities supporting clinical trials and post-marketing safety programs.
  • Provide operational and quality oversight of individual case safety report (ICSR) processing, safety database activities, follow-up, and regulatory reporting.
  • Ensure safety reporting activities meet applicable FDA requirements, ICH guidance, and relevant global regulatory standards.
  • Lead or oversee the preparation and quality review of aggregate safety reports, including Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs).
  • Oversee literature surveillance activities and support safety signal detection.
  • Review deliverables and collaborate with global operational teams to maintain consistent quality and regulatory compliance.
• Support Business Growth and Continuous Improvement
  • Serve as a pharmacovigilance subject matter expert during 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 for expanding U.S. pharmacovigilance services.
  • Identify opportunities to improve operational efficiency, service quality, and cross-functional collaboration.

Qualifications

• 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 operate independently in an evolving environment while balancing strategic priorities with hands-on operational responsibilities.

Preferred Qualifications

• 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 is a plus.

Benefits

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions.
• 401(k) Retirement Plan with generous employer matching.
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance.
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts.
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance.
• Employee Assistance Program (EAP), mental health resources, and wellness programs.
• Family-friendly benefits, including fertility support and maternity resources.
• Professional development and career growth opportunities within a leading global CRO/CDMO.