Associate Director, Pharmacovigilance

Pharmaron Beijing Co. Ltd.; États-Unis; À distance; USD 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Medical, Dental & Vision Insurance

401(k) with employer matching

PTO and company holidays

HSA contributions

Résumé du poste

Pharmaron is seeking an Associate Director, Pharmacovigilance to establish and lead its U.S. pharmacovigilance operations. As the first dedicated PV hire in the United States, you will shape the future of our U.S.

drug safety services, set up processes, and build a U.S.-based PV team while collaborating with global teams. You will independently manage PV projects, lead client discussions, develop safety plans, and ensure compliance with FDA requirements and ICH guidance in a growing CRO

Qualifications

• Bachelor's degree or higher in Pharmacy, Medicine, Nursing, Life Sciences, or related discipline.
• At least 8 years of progressive experience in pharmacovigilance or drug safety with clinical development exposure.
• Strong knowledge of FDA pharmacovigilance regulations, ICH guidance, and global safety reporting requirements.

Responsabilités

• Establish and lead U.S. pharmacovigilance operations and SOPs.
• Manage client relationships and PV programs with cross-functional teams.
• Oversee safety surveillance, ICSR processing, and regulatory reporting.
• Support business growth and continuous improvement of PV services.

Connaissances

Pharmacovigilance

FDA regulations

Project management

Client communication

Formation

Bachelor's degree in Life Sciences

Outils

PV databases

Safety reporting tools

Description du poste

Position: Associate Director, Pharmacovigilance

Location: Remote – U.S. East Coast

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

What You'll Do

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.

What We're Looking For

• 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.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture:

You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

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

As an Equal Employment Opportunity and Afforative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.