Fidelity Health Services is hiring for the position of Drug Safety Executive in Ahmedabad, Gujarat. The role focuses on pharmacovigilance case processing, Individual Case Safety Reports (ICSRs), and aggregate safety report preparation. Candidates with M.Pharm, B.Pharm, BAMS, or BHMS qualifications and a minimum of 3–4 years of relevant experience in case processing and aggregate reporting can apply by emailing their updated CV to the recruitment team.
Company Overview
Fidelity Health Services operates in the healthcare services sector. This recruitment opportunity is intended for professionals with experience in drug safety operations, pharmacovigilance case processing, safety database management, and aggregate report preparation.
Job Role & Responsibilities
Designation: Drug Safety Executive
Department: Pharmacovigilance / Drug Safety
Role: Case Processing and Aggregate Reports
Job Location: Ahmedabad, Gujarat
Job Type: Full-time, On-site
Key Responsibilities
- Enter individual case safety reports into the safety database, including regulatory, literature, spontaneous, and vendor cases.
- Process serious and non-serious adverse event cases in accordance with applicable procedures.
- Verify case data against source documents and established procedures.
- Raise queries to obtain additional information whenever required.
- Prepare and maintain aggregate report planners to track global reporting timelines.
- Review and support the preparation of Periodic Adverse Drug Experience Reports (PADER), Periodic Safety Update Reports (PSUR), and Periodic Benefit-Risk Evaluation Reports (PBRER).
- Collect and consolidate safety data from multiple sources.
- Maintain aggregate report compliance trackers and monitor reporting requirements.
- Coordinate with cross-functional teams to ensure that the necessary data is available for aggregate reports.
- Support corrective and preventive actions (CAPA) related to identified deviations.
Eligibility / Qualifications
Candidates must meet the following requirements:
Educational Qualifications
- M.Pharm
- B.Pharm
- BAMS
- BHMS
Experience
- Minimum 3–4 years of experience in pharmacovigilance case processing and aggregate report preparation.
Required Skills
- Practical knowledge of Individual Case Safety Report (ICSR) processing.
- Experience preparing and reviewing aggregate safety reports.
- Familiarity with pharmacovigilance systems such as Argus, ArisG, or Veeva.
- Understanding of safety database management and documentation practices.
- Knowledge of global pharmacovigilance regulations and compliance requirements, including FDA, EMA, and MHRA standards.
- Strong analytical, problem-solving, and decision-making skills.
- Effective communication and cross-functional coordination abilities.
Location & Salary
Job Location: Ahmedabad, Gujarat, India
Work Arrangement: Full-time, on-site
Application Process
Eligible candidates can apply by sending their updated CV to the recruitment email address below.
- Email: hrrecruitment@fidelityhs.com
- Position: Drug Safety Executive
- Subject Line: Application for Drug Safety Executive – Ahmedabad
Frequently Asked Questions
1. What is the qualification required for the Drug Safety Executive position at Fidelity Health Services?
Candidates with M.Pharm, B.Pharm, BAMS, or BHMS qualifications are eligible to apply.
2. Can freshers apply for this pharmacovigilance job?
No. The recruitment announcement specifies a minimum of 3–4 years of experience in case processing and aggregate report preparation.
3. What is the job location?
The position is based in Ahmedabad, Gujarat, and requires on-site work.
4. What is the expected salary for this position?
The company has not disclosed the salary. Candidates should confirm compensation details directly with the recruitment team.
5. How can candidates apply?
Eligible candidates can email their updated CV to hrrecruitment@fidelityhs.com.
6. What is the selection process and application deadline?
The employer has not announced the detailed selection process or application deadline. Shortlisted candidates may receive further instructions from the recruitment team.
Summary Table
| Company | Fidelity Health Services |
|---|---|
| Department Vacancies | Pharmacovigilance / Drug Safety – Drug Safety Executive |
| Qualification | M.Pharm, B.Pharm, BAMS, BHMS |
| Experience | Minimum 3–4 years |
| Location | Ahmedabad, Gujarat |