PV Coordinator – FSP

HYDERABAD (IN)REMOTEPOSTED: 8/6/2026
PHARMAFull-time
HIRING ORGANIZATIONTHERMO FISHER SCIENTIFICLife Sciences / Scientific Instruments / Biotechnology
Thermo Fisher Scientific

ROLE DEFINITION & RESPONSIBILITIES

Thermo Fisher Scientific is hiring PV Coordinators – FSP for a fully remote opportunity based in Hyderabad, India. As a PV Coordinator, you will support global pharmacovigilance projects involving adverse event management, DSMB coordination, safety documentation, project administration, Argus database activities, regulatory compliance, and client communication.

Key Responsibilities

Coordinate review of serious and non-serious adverse events.
Support protocol inquiry management.
Coordinate Data Safety Monitoring Boards (DSMB) and Endpoint Adjudication Committees (EAC).
Prepare Confidentiality Agreements, Letters of Intent, and Member Agreements.
Compile adjudication dossiers and follow-up documentation.
Schedule and facilitate global project meetings, prepare meeting minutes, and maintain project documentation.
Upload blinded and unblinded meeting materials to client portals.
Maintain audit-ready pharmacovigilance documentation.
Perform safety data entry and database reconciliation.
Manage translation activities and project budgets.
Handle hotline calls related to safety operations.
Support project training, archive management, and train junior team members when required.
Ensure compliance with FDA regulations, ICH-GCP, SOPs, and client requirements.

Eligibility Criteria

Graduation in Life Sciences (B.Pharm, M.Pharm, Pharm.D, B.Sc, M.Sc).
Minimum 1 year of Pharmacovigilance Case Processing experience.
Knowledge of FDA regulations and ICH-GCP.

REQUIRED VERIFIED SKILLS

Pharmacovigilance Case Processing
Oracle Argus Safety
Adverse Event Management
SAE Handling
DSMB Coordination
ICH-GCP

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Competitive industry package aligned with top multinational clinical research organization (CRO) standards for experienced PV professionals with Argus expertise.

ORGANIZATION CONTEXT & CULTURE

Thermo Fisher Scientific is a global leader in serving science, providing an extensive range of analytical instruments, laboratory equipment, reagents, consumables, software, and services. They partner with pharmaceutical and biotech companies, hospitals, clinical diagnostic labs, universities, research institutions, and government agencies. The company's mission is to enable its customers to make the world healthier, cleaner, and safer.

TEAM SIZE: 130,000+ employees
INDUSTRY: Life Sciences / Scientific Instruments / Biotechnology

EXPECTED CAREER ROADMAP

Offers strong global career progression within clinical research safety operations, transitioning from PV Coordinator to Senior PV Lead, Safety Manager, or Clinical Trial Operations Specialist.

APPLICATION ADVISORY

Highlight your hands-on experience with Oracle Argus Safety, SAE handling, and DSMB/EAC coordination on your resume.

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.