Looking for a senior-level opportunity in drug safety and pharmacovigilance? Clinexel is hiring a Senior Drug Safety Associate for its Navi Mumbai office. This full-time, on-site pharmacovigilance role is ideal for professionals with at least three years of industry experience in safety case processing, ICSR management, and regulatory compliance.
With increasing global focus on patient safety and risk management, experienced drug safety associates are in high demand across CROs and pharmaceutical companies. If you are aiming to grow your pharmacovigilance career in a structured CRO environment, this opportunity could be a strong next step.
Job Overview
- Position: Senior Drug Safety Associate
- Experience Required: Minimum 3 years (industry experience in similar profile)
- Employment Type: Full-Time, On-site
- Location: Clinexel Office, The Affaires, Palm Beach Road, Navi Mumbai
- Industry: Clinical Research / Pharmacovigilance / Drug Safety
Key Responsibilities โ Senior Drug Safety Associate
As a Sr Drug Safety Associate, you will be responsible for ensuring high-quality pharmacovigilance operations and regulatory compliance:
- Processing and reviewing Individual Case Safety Reports (ICSRs)
- Conducting case triage, data entry, coding (MedDRA/WHO-DD)
- Ensuring compliance with global safety reporting timelines (FDA, EMA, CDSCO)
- Performing medical review support and quality checks
- Handling aggregate reports (PSUR/PBRER support if applicable)
- Signal detection support and risk management documentation
- Coordinating with cross-functional teams and sponsors
- Maintaining inspection readiness and audit documentation
This senior drug safety role demands accuracy, regulatory awareness, and hands-on experience with global pharmacovigilance databases.
Qualifications & Eligibility
To apply for this drug safety associate job in Navi Mumbai, candidates should have:
- Minimum 3 years of pharmacovigilance / drug safety experience
- Experience in ICSR processing and safety database management
- Strong understanding of global safety reporting regulations
- Good communication and documentation skills
- Experience in CRO or pharmaceutical industry preferred
- Life sciences qualification such as:
- B.Pharm / M.Pharm
- Pharm.D
- MSc (Life Sciences, Pharmacology, Clinical Research)
Why Join Clinexel CRO?
Working at Clinexel provides exposure to:
- Global pharmacovigilance projects
- Structured CRO workflows
- Regulatory compliance standards
- Career growth in drug safety and risk management
- Professional, on-site collaborative environment
For professionals seeking stability and progression in pharmacovigilance careers in India, this opportunity offers both responsibility and growth.
How to Apply
Interested candidates can apply by sending their updated CV to:
Email Subject Line Suggestion:
Application โ Sr Drug Safety Associate โ Navi Mumbai
Apply at the earliest, as senior pharmacovigilance roles typically close quickly.
