Fidelity Health Services is seeking a highly skilled Senior Drug Safety Executive specializing in Clinical Trials Case Management for their Mumbai office. This role is critical in ensuring patient safety and regulatory compliance in global clinical trials.
Key Responsibilities:
- Triage and monitoring of clinical trial case reports.
- Safety surveillance of Serious Adverse Events (SAEs) and pregnancy reports in clinical studies.
- Adverse event reconciliation for company-sponsored trials.
- Drafting and reviewing Safety Monitoring Plans (SMPs).
- Evaluating safety sections in study-specific documents.
- Collaborating with investigator sites, project teams, and case processing teams for follow-up data collection.
About Fidelity Health Services
Fidelity Health Services is a reputed name in pharmaceutical and healthcare research, specializing in drug safety, clinical trials, and pharmacovigilance. With a commitment to patient safety and regulatory excellence, the company supports global clinical studies, ensuring compliance with ICH-GCP, FDA, and EMA guidelines.
Eligibility Criteria
Education & Experience:
- B.Pharm/M.Pharm/BDS/BAMS (Mandatory).
- 4–6 years of relevant experience in drug safety, pharmacovigilance, or clinical trial case management.
- Strong understanding of SAE reporting, MedDRA coding, and clinical trial protocols.
Preferred Skills:
- Proficiency in Argus/Safety Database software.
- Knowledge of FDA 21 CFR Part 11, CIOMS, and E2B guidelines.
- Excellent analytical and communication skills.
How to Apply
Interested candidates meeting the eligibility criteria can email their updated CV to:
Email: hrrecruitement@fidelityhs.com
Subject Line: “Application for Senior Drug Safety Executive – Job Code FHS/2025/INS/16”
Note: Only shortlisted candidates will be contacted for further interviews.
