Job Description

The Associate Specialist, PV is responsible for undertaking specified PV activities (as delegated/assigned by their manager) and with oversight by their manager or a designated PV colleague. The Associate Specialist, PV is responsible for ensuring adherence to all applicable regulations.

1. Assists with execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned. Activities may include but are not limited to management of local PV agreements, local due diligence activities, Post approval Safety Monitoring Program (PSMP) implementation, scheduling and submitting aggregate safety reports.

2. Assists with day-to-day adverse events case management which may include case intake (where needed), translations (English and/or local language, (as applicable)), acknowledgments, follow-up and submission activities in accordance with PV procedures and country regulations.

3. Supports local PV audits and inspections when requested.

4. Participates in issue management/compliance activities and assists in coordinating/preparing the necessary local corrective actions.

5. Supports appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per local procedure and local legislations.

6. May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).

7. Translates or QCs translation of applicable PV documents.

8. Responsible for filing, storage and archiving of safety-related documentation in accordance with company policies and local requirements.

9. Participates in special projects or rotational assignments within or outside of IPV as part of their professional development.

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

English level:

Advance (desirable)

Education:

Professionals on health science, chemical, biologists, pharmaceuticals, etc.

Requirements:

Organization

Manage of priorities

Sense of urgency

Microsoft office package

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
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:

Temporary (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Administrative Policies, Administrative Policies, Adverse Events, Aviation Safety Management, Budget Development, Change Management, Clinical Supply Chain Management, Clinical Trial Management, Data Analysis, Digital Marketing, Feasibility Studies, Implementation Management, Issue Management, Management Process, Office Tools, Project Documentation, Project Implementations, Project Management, Project Management Tools, Project Planning, Regulatory Compliance, Risk Control Assessment, Risk Management, Risk Management and Mitigation, Risk Minimization {+ 4 more}

Preferred Skills:

Job Posting End Date:

09/30/2025

*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.