Pharmacovigilance Associate Specialist - Safety & Compliance

MSD; Jakarta Pusat; Hybrid; IDR 180,000,000 - 300,000,000; Full time

Job summary

MSD is seeking an Associate Specialist, PV to support local pharmacovigilance activities in Indonesia. The role involves executing PV processes, case management, audits, and compliance with local regulations, under supervision.

You will help maintain PV procedures, support risk minimization measures, and assist translations and literature screening as required. The position requires a health/science degree, English fluency, and strong communication and organizational skills.

Qualifications

• Health, life science, or medical science degree required.
• Experience in pharma industry preferred.
• Fluent English (written and spoken) with proficiency in local language.

Responsibilities

• Assist with execution of local PV processes and activities in collaboration with internal teams and external parties.
• Support day-to-day adverse events case management and translations as needed.
• Support PV audits and inspections when requested.
• Coordinate local corrective actions and issue management activities.
• Maintain local PV procedures and controlled documents.
• Assist PV self-inspections as required by PV regulations.
• Assist in implementation and oversight of Risk Min./Mitigation Measures locally.
• Possibly manage local literature screening and assessment per local requirements.
• Support business continuity plan implementations.
• QC translations of PV documents and ensure proper filing/storage of safety records.

Skills

Action Plan Development

Adverse Event Report

Communication

Compliance Activities

Compliance Investigations

Corrective Action

Data Analysis

Data Management

Data Processing

Data Quality Assurance

Detail-Oriented

Document Controls

Drug Safety Surveillance

Employee Training

Functional Management

Medication Safety

Patient Safety

Personnel Selection

Pharmacology

Pharmacovigilance

Policy Implementation

Procedure Development

Protocol Development

Regulatory Audits

Education

Health, life science, or medical science degree

Job description

MSD is seeking an Associate Specialist, PV to support local pharmacovigilance activities in Indonesia. The role involves executing PV processes, case management, audits, and compliance with local regulations, under supervision.

You will help maintain PV procedures, support risk minimization measures, and assist translations and literature screening as required. The position requires a health/science degree, English fluency, and strong communication and organizational skills.