Syneos Health has announced exciting Safety & PV Specialist I & II opportunities for experienced Pharmacovigilance professionals in Hyderabad and Gurugram. Candidates with hands-on experience in ICSR processing, MedDRA coding, narrative writing, literature screening, quality review, and safety database management are encouraged to apply.
If you are looking for Pharmacovigilance Jobs in India, Drug Safety Jobs, ICSR Processing Jobs, or Safety Specialist Jobs at Syneos Health, this opportunity offers an excellent chance to work with one of the world’s leading biopharmaceutical solutions organizations.
Job Overview
| Details | Information |
|---|---|
| Company | Syneos Health |
| Job Role | Safety & PV Specialist I & II |
| Job Type | Full-Time |
| Work Mode | Office-Based |
| Location | Hyderabad, Gurugram |
| Experience | Specialist I: Minimum 2.6 Years โข Specialist II: Minimum 4 Years |
| Qualification | B.Pharm, M.Pharm, BDS, BMS, MBBS |
| Preferred | Immediate Joiners |
Key Responsibilities
As a Safety & PV Specialist, you will support global pharmacovigilance operations while ensuring compliance with international safety regulations.
Major responsibilities include:
- Process Individual Case Safety Reports (ICSRs)
- Perform ICSR triage and assess reportability
- Enter case information into safety databases
- Code adverse events using MedDRA
- Code medical history, concomitant medications, and laboratory tests
- Prepare accurate narrative summaries
- Follow up on missing case information
- Generate expedited safety reports within regulatory timelines
- Maintain pharmacovigilance tracking systems
- Conduct literature screening and safety review
- Perform drug coding and dictionary maintenance
- Validate and submit xEVMPD product records
- Support SPOR and IDMP activities
- Identify and manage duplicate ICSRs
- Perform quality review of safety cases
- Maintain Trial Master File (TMF) documentation
- Ensure compliance with SOPs, GCP, GVP, ICH Guidelines and global regulations
- Participate in internal and external audits
- Collaborate with global safety teams and sponsors
Required Qualifications
Candidates should possess any one of the following qualifications:
- B.Pharm
- M.Pharm
- BDS
- BMS
- MBBS
Note: B.Sc and M.Sc candidates are not eligible for this role as per the employer’s stated criteria.
Experience Required
Safety & PV Specialist I
- Minimum 2.6 years of Pharmacovigilance experience
Safety & PV Specialist II
- Minimum 4 years of Pharmacovigilance experience
Immediate joiners will be given preference.
Preferred Skills
Candidates with experience in the following areas will have an advantage:
- Pharmacovigilance Operations
- ICSR Processing
- MedDRA Coding
- WHO Drug Coding
- Narrative Writing
- Safety Database Management
- Expedited Reporting
- Literature Screening
- Duplicate Detection
- Quality Review of ICSRs
- xEVMPD
- SPOR
- IDMP
- TMF Documentation
- GCP
- GVP
- ICH Guidelines
- Regulatory Compliance
Why Join Syneos Health?
Syneos Health is among the world’s leading biopharmaceutical solutions organizations.
Employees benefit from:
- Global career growth opportunities
- Structured learning and development
- Technical and therapeutic area training
- Competitive rewards and recognition
- Inclusive workplace culture
- Exposure to global Pharmacovigilance projects
- Work on innovative medicines and clinical development programs
- Opportunity to collaborate with international teams
About Syneos Health
Syneos Health operates across 110 countries with more than 29,000 employees worldwide.
According to the company, over the last five years it has contributed to:
- 94% of Novel FDA Approved Drugs
- 95% of EMA Authorized Products
- More than 200 clinical studies
- 73,000+ study sites
- 675,000+ clinical trial participants
How to Apply
