Thermo Fisher Scientific is hiring PV Coordinators โ FSP for a fully remote opportunity based in Hyderabad, India. This is an excellent opportunity for professionals with 1+ years of Pharmacovigilance (PV) Case Processing experience who want to work with one of the world’s leading clinical research organizations.
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. If you have experience in Argus Safety Database, ICH-GCP, and safety case processing, this role offers strong career growth within Thermo Fisher Scientific’s global safety operations.
Job Details
| Details | Information |
|---|---|
| Company | Thermo Fisher Scientific |
| Position | PV Coordinator โ FSP |
| Job Type | Full-Time |
| Work Mode | Fully Remote |
| Base Location | Hyderabad, India |
| Department | Pharmacovigilance |
| Experience | 1+ Years |
| Job ID | R-01362187 |
Key Responsibilities
As a PV Coordinator, you will:
- 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 and archive management
- Train junior team members when required
- Ensure compliance with FDA regulations, ICH-GCP, SOPs, and client requirements
Eligibility Criteria
Applicants should have:
- Graduation in Life Sciences (preferred)
- Minimum 1 year of Pharmacovigilance Case Processing experience
- Experience using Oracle Argus Safety Database (preferred/required)
- Good understanding of Pharmacovigilance workflows
- Knowledge of FDA regulations and ICH-GCP
- Excellent communication and coordination skills
- Strong MS Office skills (Excel, Word, PowerPoint)
- Ability to work independently and manage multiple priorities
Preferred Skills
- Pharmacovigilance Case Processing
- Oracle Argus Safety
- Adverse Event Management
- Serious Adverse Event (SAE) Handling
- DSMB Coordination
- Safety Documentation
- Audit Readiness
- Data Privacy Compliance
- Project Coordination
- Medical Documentation
- Regulatory Compliance
- Client Communication
Why Join Thermo Fisher Scientific?
- Fully Remote Work Opportunity
- Global Pharmacovigilance Projects
- Work with Top Pharmaceutical Companies
- International Clinical Trial Exposure
- Career Growth in Drug Safety
- Collaborative Global Teams
- Professional Development Programs
- Stable Multinational Organization
Who Should Apply?
This role is ideal for:
- B.Pharm Graduates
- M.Pharm Graduates
- Pharm.D Graduates
- B.Sc Life Sciences
- M.Sc Life Sciences
- Candidates with 1+ years of PV Case Processing experience
- Professionals experienced in Oracle Argus Safety
How to Apply
