Fidelity Health Services is hiring a Drug Safety Executive for a full-time, on-site position in Ahmedabad. The role focuses on Individual Case Safety Report (ICSR) processing and the review of aggregate safety reports, including PADER, PSUR, and PBRER.
Job Details
| Particulars | Details |
|---|---|
| Company | Fidelity Health Services |
| Job Title | Drug Safety Executive |
| Job Location | Ahmedabad, Gujarat |
| Employment Type | Full-time |
| Work Mode | On-site |
| Job Profile | ICSR Processing and Aggregate Reports |
| Application Email | hrrecruitment@fidelityhs.com |
Position: Drug Safety Executive
The selected candidate will handle individual case safety report data entry and review aggregate reports as part of pharmacovigilance operations.
Responsibilities
- Enter data for Individual Case Safety Reports (ICSRs).
- Process regulatory, literature, spontaneous, and vendor cases.
- Review Periodic Adverse Drug Experience Reports (PADER).
- Review Periodic Safety Update Reports (PSUR).
- Review Periodic Benefit-Risk Evaluation Reports (PBRER).
- Maintain pharmacovigilance database records and documentation in accordance with applicable practices.
Eligibility and Qualifications
Candidates should have a strong foundation in case processing and aggregate report drafting within pharmacovigilance systems.
Relevant qualifications include:
- Knowledge of ICSR processing and aggregate safety reports.
- Familiarity with pharmacovigilance systems such as Argus, ArisG, or Veeva.
- Understanding of global pharmacovigilance regulations and compliance standards, including FDA, EMA, and MHRA requirements.
Required Skills
- Analytical thinking and problem-solving.
- Decision-making skills relevant to drug safety assessments.
- Pharmacovigilance database management.
- Documentation and compliance practices.
- Effective communication and collaboration with cross-functional teams and stakeholders.
How to Apply
Interested candidates can send their CV to the Fidelity Health Services recruitment team.
Email: hrrecruitment@fidelityhs.com
Subject suggestion: Application for Drug Safety Executive – Ahmedabad
