Fidelity Health Services is hiring for two drug safety-related roles in Ahmedabad, Gujarat. The openings focus on pharmacovigilance case processing, Individual Case Safety Reports (ICSRs), and aggregate safety report review. Candidates with 1–2 years of case processing experience are preferred for the Drug Safety Executive position.
Job Details
| Particulars | Details |
|---|---|
| Company | Fidelity Health Services |
| Job Title | Drug Safety Executive |
| Job Code | FHS/2026/INS/33 |
| Job Type | Full-time |
| Work Mode | On-site |
| Location | Ahmedabad, Gujarat |
| Qualification | B.Pharm / M.Pharm |
| Experience | 1–2 years in case processing |
| Preferred Candidates | Immediate joiners |
Positions Available
Fidelity Health Services is hiring for two distinct pharmacovigilance roles:
- ICSR Case Processing: Focused on individual case safety report data entry, case management, quality checks, and literature case processing.
- Aggregate Report Review: Focused on reviewing periodic safety reports, including PADER, PSUR, and PBRER.
Responsibilities
1. ICSR Case Processing
- Perform duplicate checks, book-in, and case management in the Oracle Argus Safety database.
- Verify data accuracy against source documents and established procedures.
- Enter and conduct quality reviews of Individual Case Safety Reports (ICSRs).
- Process regulatory, spontaneous, vendor, and literature cases.
- Perform data corrections for ICSRs identified during signal reports, Health Hazard Assessment (HHA) reports, routine signal reviews, Post-Process Quality Checks (PPQC), and FDA Adverse Event Reporting System (FAERS) reviews.
- Follow up on safety cases and generate action items in Argus.
2. Aggregate Report Review
- Review periodic aggregate safety reports.
- Work with Periodic Adverse Drug Experience Reports (PADERs).
- Review Periodic Safety Update Reports (PSURs).
- Review Periodic Benefit-Risk Evaluation Reports (PBRERs).
Eligibility and Qualifications
Candidates applying for these pharmacovigilance jobs should meet the following requirements:
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- B.Pharm or M.Pharm qualification.
- 1–2 years of experience in case processing for the Drug Safety Executive position.
- Knowledge of ICSR processing and aggregate safety reports, depending on the role.
Required Skills
- Knowledge of pharmacovigilance case processing and aggregate report preparation or review.
- Familiarity with safety databases such as Oracle Argus, ArisG, or Veeva.
- Understanding of database management and documentation practices.
- Knowledge of global pharmacovigilance regulations, including FDA, EMA, and MHRA requirements.
- Analytical thinking, problem-solving, and decision-making skills.
- Effective communication and collaboration with cross-functional teams.
Application Details
Interested candidates can share their updated CV with Fidelity Health Services by email.
- Company: Fidelity Health Services
- Job Code: FHS/2026/INS/33
- Location: Ahmedabad, Gujarat
- Email: hrrecruitment@fidelityhs.com
- Preference: Immediate joiners
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