Job Description

PV Specialist is responsible for PV activities (as delegated/assigned by their manager) which may include but is not limited to PV Intake activities (including reconciliation and follow-up), Individual case safety report (ICSR) and aggregate submissions, compliance monitoring, management and negotiation of local PV agreements, local due diligence activities, supporting audits and inspections and related readiness activities, authoring local SOPs, conducting local training, and archiving and is able to perform these tasks with minimal supervision.

1. Responsible for day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations.

2. 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.

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

4. Supports local PV audits and inspections including readiness activities and supports audits of business partners/vendors including the development of CAPAs in response to findings/observations as assigned.

5. Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reports.

6. Assists in developing and maintaining 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.

7. Supports PV self-inspections as required by PV Legislations (where applicable).

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

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

10. Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.

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

Education:

Bachelor’s in Pharmacy, Nursing or Bio/Life Science (Pharmacy major preferred)

Work Experience:

Experience in the pharmaceutical industry is preferredGeneral knowledge of AE reporting requirements and relevant PV regulations is preferred, but is not required / Entry level allowed

Job-specific competencies & skills:

Must be fluent in English (written and spoken) while proficient in local languageStrong communications, organizational, and time management skillsAbility to work in partnership with others (internally and externally) to accomplish quality goalsAbility to interface broadly with colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations. Demonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business. 

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

This is 1 year contract position for maternity leave

이 포지션은 육아휴직 대체 1년 계약직입니다.

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:

Adaptability, Adaptability, Adverse Event Report, Applied Engineering, Case Management, Clinical Trial Management, Communication, Complaint Management, Compliance Investigations, Data Analysis, Data Management, Detail-Oriented, Documentations, Drug Safety Surveillance, Employee Training, Incident Management, Management Process, Patient Safety, Periodic Safety Update Reports, Pharmaceutical Management, Pharmacovigilance, Production Readiness, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Consulting {+ 3 more}

 Preferred Skills:

Job Posting End Date:

06/27/2025

*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.

Requisition ID:R353933