Associate Director, Pharmacovigilance

Merck; United States; Remote; USD 120,000 - 150,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking an Associate Director responsible for adverse event management and pharmacovigilance. The role involves overseeing compliance, managing local processes, and acting as a liaison with health authorities. Candidates should possess strong leadership and communication skills, along with a relevant degree and extensive experience in safety and pharmacovigilance. This is an opportunity to lead and drive process improvements in a dynamic environment.

Qualifications

• Minimum of 4 years in pharmaceutical safety and pharmacovigilance.
• Supervisory experience preferred.

Responsibilities

• Serve as the point of contact for local Health Authorities regarding PV questions.
• Ensure compliance with local laws and regulations.
• Provide medical review of ICSRs and oversee local PV processes.

Skills

Leadership

Communication

Decision-making

Problem-solving

Organizational

Negotiation

Strategic Thinking

Clinical Research

Education

Health, life science, or medical science degree

Job description

The Associate Director is responsible for adverse event management, including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring.

The Associate Director also handles other delegated activities (as assigned by the PV Lead), such as managing PV agreements, conducting due diligence, participating in audits and inspections, reviewing compliance initiatives, SOP management, local training, safety communication, people development, and special projects. They are expected to work independently on these activities.

They may serve as the Back-up (BU) Local PV Contact / BU Local Responsible PV person as required by local legislation. In the PV Lead's absence, they manage day-to-day PV activities and serve as their back-up. Key responsibilities include:

1. Serving as the point of contact for local Health Authorities regarding PV questions, when designated by the PV Lead.
2. Ensuring compliance with local laws and regulations when acting as the Local Responsible PV Person Backup.
3. Providing medical review of ICSRs, including narrative accuracy, medical assessment, causality, and compliance with reporting timelines.
4. Overseeing and executing local PV processes collaboratively.
5. Coordinating translation and QC of PV documents as needed.
6. Supporting PV audits, inspections, and readiness activities, including CAPA development.
7. Reporting adverse experiences, events, or product complaints in line with corporate policies.
8. Participating in and supporting audits of contractual partners/vendors.
9. Preparing corrective actions for compliance issues.
10. Developing and maintaining local procedures to ensure data quality and process efficiency.
11. Supporting PV training and maintaining related documentation.
12. Conducting PV self-inspections and identifying procedural gaps.
13. Completing required trainings and supporting training of staff and partners.
14. Managing literature screening and assessment.
15. Monitoring Health Authority websites for safety updates and requirements.
16. Ensuring PV language is included in country agreements and performing due diligence on partners.
17. Implementing Post-approval Safety Monitoring Programs as per local legislation.
18. Reviewing and approving local initiatives and programs for PV compliance.
19. Coordinating submission activities for reports like PSURs and RMPs.
20. Overseeing local risk minimization measures and ensuring compliance.
21. Supporting external engagement and industry forums.
22. Implementing business continuity plans.
23. Managing safety documentation filing, storage, and archiving.
24. Serving as a local PV Subject Matter Expert.
25. Liaising with business units on safety activities and strategic decisions.
26. Representing PV in cross-functional and external forums.
27. Participating in company committees related to PV.
28. Reviewing ICSRs in the safety database, including causality and listedness assessments, especially for MSR standards.
29. Participating in special projects or rotations for professional development.

Education: Health, life science, or medical science degree or equivalent experience (discretion allowed by hiring manager).

Work Experience: Minimum of 4 years in pharmaceutical safety and pharmacovigilance, supervisory experience preferred. Must have strong leadership, communication, decision-making, and problem-solving skills, with in-depth PV knowledge, including audits and inspections.

Job-specific skills: Clinical research experience, fluency in English and proficiency in the local language, ability to travel, excellent interpersonal, organizational, negotiation, and strategic thinking skills, and ability to work independently and drive process improvements.

Current Employees apply HERE

Current Contingent Workers apply HERE