Pharmacovigilance Specialist

Jakarta - Indonesia

Monthly Salary: Not Disclosed

Posted on: 16 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description

Job Description:

Responsible for PV activities which may include but is not limited to:

local PV processes and activities in collaboration with internal functional areas and external parties 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 and corrective action activities authoring local SOPs conducting local training local literature screening and assessment ensuring the implementation of risk minimization measures and additional risk minimization measures support local implementation of applicable business continuity plans and archiving/ filings and is able to perform these tasks with minimal supervision.

Education:

Health life science or medical science degree or equivalent by education/experience

Qualification:

Have a minimum 1 year of industry experience in pharmacovigilance is preferred
General knowledge of AE reporting requirements and relevant PV regulations is preferred
Must be fluent in English (written and spoken) while proficient in local language
Ability to work in partnership with others (internally and externally) to accomplish quality goals
Ability to interface broadlywith 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.

Required Skills:

Adaptability Adaptability Adverse Event Report Business Continuity Business Process Improvements Clinical Trial Management Complaint Management Compliance Investigations Compliance Reviews Corrective Action Management Data Analysis Data Management Detail-Oriented Drug Safety Surveillance Employee Training Financial Process Improvement Immunology IS Audit Life Science Management Process Medical Care Pharmacovigilance Regulatory Communications Regulatory Compliance Risk Management 2 more

Preferred Skills:

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Employee Status:

Temporary (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/22/2026

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

Required Experience:

Job DescriptionJob Description: Responsible for PV activities which may include but is not limited to:local PV processes and activities in collaboration with internal functional areas and external parties PV Intake activities (including reconciliation and follow-up) Individual case safety report (IC...