Job Description

The PV Lead is responsible for aggregate and individual case safety report (ICSR) health authority submissions and ensuring all PV activities are conducted in compliance with local laws and regulations, company policies and procedures.

The PV Lead is the primary point of contact for the local Health Authority and serves as the local Qualified Person for PV (QPPV) / Local PV Contact / Local Responsible PV Person for their country (& supported countries where applicable) and ensures a back-up as required per local PV legislation.

The PV Lead interacts with the Managing Director, Global Clinical Trial Operations (GCTO), Regulatory Affairs International (RAI), Global Medical and Scientific Affairs (GMSA), and other business unit colleagues in their residing country and supported countries (as applicable) to ensure alignment on matters impacting PV. The PV Lead may be a part of the local leadership team and is a member of the local/regional Medical Governance Council and may undertake additional activities/special projects as assigned.

Some responsibilities may be delegated; however, the PV Lead remains accountable. The items listed below are activities that can be performed by the role and is applicable for all supported countries. Additional local specific tasks, countries covered and responsibilities of the local QPPV, Local PV Contact / Local Responsible PV Person may be further described in the section below entitled “Additional Local Specific Activities”.

1. Responsible for strategic leadership of the PV short and long-term country objectives including department structure/function/processes, PV regulatory Intelligence, and local Health Authority policy development / implementation.

2. Responsible for management of local resources, as applicable, including recruitment, training, development, and performance management

3. Serves as the local Qualified Person for PV (QPPV) / Local PV Contact / Local Responsible PV Person for their country (& supported countries where applicable) and ensures a back-up as required per local PV legislation.

4. As the local QPPV / Local PV Contact / Local Responsible PV Person complies with all requirements mentioned in the local laws and regulations.

5. Oversees all daily PV processes and activities in collaboration with internal functional areas and external parties as applicable.

6. Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.

7. Ensures that trainings have been assigned to the PV team (if applicable). Ensures new hires complete the required/applicable training assigned at time of hire and after hire by the due date, before performing the activity.

8. Responsible for ensuring maintenance of the local training matrix and new hire onboarding plans.

9. Coordinates the filing, storage and archiving of safety-related documentation in accordance with company’s policies and local requirements.

10. Participates in compliance activities and coordinates/supports the preparation of necessary documents (e.g., Issues management documentation, etc.) locally for deviations from internal policies and procedures.

11. Ensures audit / inspection readiness, coordinates, leads, and actively participates in local audits and inspections.

12. Ensures local PV self-inspections are conducted as required by PV Legislations (where applicable).

13. Provides recommendations for corrective and preventive actions (CAPA), tracks CAPA commitments to address findings/observations and monitors until closure.

14. Participates in and supports audits of contractual partners/vendors as necessary.

15. Responsible for escalating country PV issues and potential safety issues.

16. Responsible for ensuring Health Authority Website Monitoring for potential safety issues, safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation (as applicable).

17. Responsible for managing and performing Local literature screening and assessment in accordance with company procedure and local requirements (as applicable). If process is executed by a vendor, ensures oversight.

18. Defines, develops, and maintains local standards, procedures, and controlled documents in alignment with regional and global requirements (e.g., SOPs, training materials, CCPDs (where applicable)).

19. Proactively identifies procedural gaps and challenges, implementing solutions in collaboration with relevant stakeholders.

20. Supports/provides/oversee pharmacovigilance training of local company staff, distributors, vendors, and business partners when necessary.

21. Responsible for ensuring appropriate PV language is included in country PV agreements, liaising with business partners, vendors and Alliance Managers as required, overseeing local qualification/due diligence activities (when required), compliance reviews, and ensuring maintenance of the business partner data tracking system.

22. Responsible for PV engagement in relevant external associations/industry forums, and regulatory authorities, as applicable.

23. Responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable.

24. Responsible for scheduling and coordinating submission activities for Aggregate Safety Reports (e.g., PSURs) to the local Health Authority in compliance with company procedures and local legislation (as applicable).

25. Collaborate with internal stakeholders to ensure local implementation of Post approval Safety Monitoring Program (PSMP) plan in compliance with local legislation (where applicable)

26. Responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per policy while ensures compliance with local legislations.

27. Responsible for preparing/maintaining/submitting local Risk Management Plans to the local HA (as applicable).

28. Responsible for local implementation of applicable business continuity plans (as applicable)

29. Provides expertise in the planning, execution, and maintenance of major projects.

30. Represents PV in cross-functional organizational and alliance partner forums as needed.

31. Serves as local Subject Matter Expert on relevant PV regulations, processes, and procedures.

32. Liaises with the local business units to provide input on strategic decisions (e.g., new clinical trials, product launches, product recall, etc.)

33. Participates on local company committees and councils (as appropriate) for matters impacting PV.

Education:

· Pharmacist or Medical Doctor

Work Experience:

· At least 3 years of experience in the pharmaceutical industry with a specific focus on safety and pharmacovigilance related activities

· Experience supervising/managing people is preferred.

· Experience collaborating across functional areas and countries

· Detailed knowledge of AE reporting requirements, relevant PV regulations and PV quality management systems

· Experience with PV audits and/or PV Health Authority Inspections

· Fluent in English (written and spoken) while proficient in local language

Job-specific competencies & skills:

· Ability to travel within the region and globally

· Demonstrate strong leadership and proficient interpersonal communications, organizational, and presentation skills.

· Advance negotiation and influencing skills.

· Ability to work in partnership with others (internally and externally).

· Demonstrates advanced skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business

· Advanced ability for identifying, understanding and resolving problems.

· Demonstrates advanced strategic thinking and project management skills including prioritization of tasks

Required Skills:

Adaptability, Adaptability, Adverse Event Report, Auditing, Audit Inspections, Business Continuity, Business Decisions, Clinical Trials, Communication, Compliance Monitoring, Compliance Reviews, Cross-Cultural Collaboration, Data Management, Global Program Development, Leadership, Maintenance Management, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Process Improvements, Product Recalls, Project Management, Regulatory Compliance, Regulatory Reporting, Risk Minimization, Safety Procedures {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

11/28/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.