Job Description

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

The Associate Director, PV is also responsible for other activities (as delegated by the PV Lead) which may include but are not limited to: management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, review of local initiatives for compliance with PV requirements, SOP management, local training, communication of safety issues, people development, special projects as assigned, and is able to work on these delegated activities independently.

The PV Associate Director may serve as the Back-up (BU) Local PV Contact / BU Local Responsible PV person as required per local PV legislation. In the absence of the PV Lead, they manage day-to-day PV activities and serve as their back-up.

The primary activities include and not limited to:

1)Serves as the point of contact for the local Health Authority for PV related questions when assigned by the PV Lead and in their absence.

2)If serving as the Local Responsible PV Person Backup, complies with all requirements mentioned in the local laws and regulations.

3) May be responsible for management of one or more direct reports including recruitment, training, development, and performance management as applicable.

4) Oversees and responsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.

5) May coordinate translation of PV documents and ensure a QC check is performed by a second person for any in-house translations (as applicable).

6)Serves as a SME and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.

7) Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy 01: Patient Safety.

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

9)Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reporting countries covered by the country operation.

10) Develops and maintains local procedures (in compliance with regional and global standards), to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.

11)Supports PV Lead in maintaining the local PV Training matrix and onboarding plans as assigned. 12)Supports the development and maintenance of local PV controlled documents (e.g.,

Company Core Pharmacovigilance Documents, training materials, etc. as applicable) ensuring that they are kept current.

13)Conducts and/or supports PV self-inspections as required by PV Legislations (where applicable). 14)Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.

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

16)Supports training of local company staff, distributors, vendors, and business partners and can provide training as applicable.

17)Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).

18) May be responsible for 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).

19)May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with business partners, vendors and Alliance Managers as required, performing local qualification/due diligence activities, compliance reviews, and ensuring maintenance of the business partner data tracking system.

20) As delegated by PV Lead, collaborates with internal stakeholders to ensure local implementation of Post approval Safety Monitoring Program (PSMP) plan in compliance with local legislation (as applicable).

21) May be 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.

22)As assigned by PV Lead, responsible for scheduling and coordinating submission activities for PSURs and other Aggregate Reports to the local Health Authority in compliance with company procedures and local legislation (as applicable).

23)As assigned by PV Lead, responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures, and Additional Risk Minimization Measures locally as per department policy and ensures compliance with local legislations.

24)As assigned by PV Lead, prepare/maintain/submit local RMPs to the local HA (as applicable).

25) May participate in PV engagement in relevant external associations/industry forums, and regulatory authorities, as applicable

26)Support local implementation of applicable business continuity plans (as applicable)

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

28)Serves as local Subject Matter Expert on relevant PV regulations, processes and procedures. 29)Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions.

30)Represents PV in cross-functional organizational and alliance partner forums as needed. 31)Participates on local company committees and councils for matters impacting PV as assigned. 32)Responsible for individual case safety reports (ICSR) review in the safety database; assessing specific types of the local cases from China that are in scope for MSR to perform medical review of ICSR (including causality and listedness determination) per MSR standards and subsequently complete to the next applicable workflow state (Unblinding or Distribution), (as applicable, specializing for staff with medical background and taking the role of MSR)

33) May participate on special projects or rotational assignments within or outside of China PV as part of their professional development.

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/1/2025

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