Job Summary
Fidelity Health Services is currently seeking a detail-oriented and experienced professional to join our team as a Drug Safety Executive / Senior Executive at our Airoli, Mumbai facility. This onsite role is ideal for individuals with 2–4 years of experience in pharmacovigilance who are looking to advance their careers in global drug safety operations. The successful candidate will play a critical role in maintaining high standards of patient safety through diligent ICSR processing, literature review, and compliance with international regulatory guidelines.
Job Overview
- Position: Drug Safety Executive / Sr. Executive
- Location: Airoli, Mumbai (Onsite)
- Job Code: FHS/2026/INS/28
- Experience Level: 2–4 years
- Industry: Pharmacovigilance / Drug Safety
- Employment Type: Full-time (Immediate joiners preferred)
Key Responsibilities
As a member of our pharmacovigilance team, you will be responsible for the end-to-end management of safety data. Your primary duties will include:
- Case Processing & Triage: Performing accurate triage of Individual Case Safety Reports (ICSR), including MLM, L2A, and ASPR cases.
- Literature Review: Conducting systematic literature reviews using EMBASE and other scientific databases to identify potential safety signals.
- Database Management: Managing ICSR case processing, performing duplicate checks, and actively monitoring global safety databases, including Canada Vigilance and TGA DAEN.
- Regulatory Reporting: Reviewing Adverse Events (AE), Product Quality Complaints (PQC), and Medical Information (MI) to ensure timely and accurate reporting.
- Compliance & Documentation: Supporting the maintenance and updates of Standard Operating Procedures (SOPs) and ensuring all processes strictly adhere to Good Pharmacovigilance Practices (GVP).
- Follow-up Coordination: Managing spontaneous reports and conducting follow-up activities to obtain necessary information for case completion.
Requirements
We are looking for candidates who possess the following qualifications and professional experience:
- Education: A degree in B.Pharm, M.Pharm, BAMS, or a related Life Sciences discipline.
- Experience: 2–4 years of dedicated experience within the pharmacovigilance or drug safety domain.
- Technical Proficiency:
- Hands-on experience with Oracle Argus Safety is essential.
- Familiarity with MLM tools and EMBASE.
- Core Competencies:
- Strong working knowledge of GVP and global PV regulations.
- Ability to perform high-quality case triage and literature reviews.
- Excellent communication, analytical, and teamwork skills.
Benefits
Joining the team at Fidelity Health Services offers significant professional growth opportunities:
- Global Exposure: Gain valuable experience working with international safety databases and global pharmacovigilance systems.
- Professional Development: Deepen your expertise in the full lifecycle of ICSR management and regulatory compliance.
- Competitive Compensation: We offer a salary range of ₹4.5 LPA – ₹8 LPA, commensurate with your experience and technical skillset.
- Industry Impact: Play a vital role in a high-demand sector focused on ensuring drug safety and patient well-being.
How to Apply
If you are a dedicated professional passionate about drug safety and meet the above requirements, we encourage you to apply for this position.
To submit your application, please send your updated resume, clearly mentioning the Job Code: FHS/2026/INS/28 in the subject line of your email. Please ensure your contact details and current salary information are clearly stated. We look forward to reviewing your qualifications.