Senior Drug Safety Associate Job in Navi Mumbai at Clinexel CRO. Apply for pharmacovigilance role with 3+ years experience.
Pharmacovigilance professionals seeking a senior-level opportunity in drug safety can now explore a promising opening in Navi Mumbai. Clinexel CRO is recruiting for the position of Senior Drug Safety Associate, inviting applications from experienced candidates with strong expertise in ICSR processing and global safety reporting.
With increasing regulatory expectations worldwide, the demand for skilled drug safety professionals continues to grow. This full-time, on-site role offers an excellent opportunity to advance your pharmacovigilance career within a structured and compliance-focused CRO environment. Senior Drug Safety Associate Job in Navi Mumbai at Clinexel CRO
Company Overview
Clinexel CRO is a clinical research organization providing services across pharmacovigilance, clinical research, and regulatory support. The company works with sponsors and global clients to ensure regulatory compliance, patient safety, and efficient clinical development processes. Clinexel emphasizes quality-driven operations, structured workflows, and adherence to international safety standards.
Job Location & Employment Type
- Position: Senior Drug Safety Associate
- Location: The Affaires, Palm Beach Road, Navi Mumbai
- Employment Type: Full-Time (On-site)
- Experience Required: Minimum 3 Years
- Industry: Clinical Research / Pharmacovigilance / Drug Safety
This role is designed for professionals who already possess hands-on experience in safety case processing and regulatory reporting. Senior Drug Safety Associate Job in Navi Mumbai at Clinexel CRO
Department Overview – Pharmacovigilance / Drug Safety
The Drug Safety department ensures continuous monitoring of medicinal product safety throughout the lifecycle. Professionals in this function are responsible for identifying, evaluating, and reporting adverse events in compliance with global health authorities such as FDA, EMA, and CDSCO.
The Senior Drug Safety Associate will play a key role in managing safety case workflows and maintaining regulatory compliance standards. Senior Drug Safety Associate Job in Navi Mumbai at Clinexel CRO
Key Roles & Responsibilities
The selected candidate will be responsible for:
- Processing and reviewing Individual Case Safety Reports (ICSRs).
- Performing case triage, data entry, and coding using MedDRA and WHO-DD dictionaries.
- Ensuring adherence to global safety reporting timelines and regulatory requirements (FDA, EMA, CDSCO).
- Conducting quality checks and supporting medical review processes.
- Assisting with preparation and review of aggregate safety reports such as PSUR and PBRER (if applicable).
- Supporting signal detection activities and maintaining risk management documentation.
- Coordinating with sponsors and cross-functional teams to resolve safety queries.
- Maintaining audit and inspection readiness through accurate documentation practices.
This role requires high attention to detail, regulatory awareness, and the ability to manage case volumes efficiently within defined timelines.
Eligibility Criteria
Educational Qualification
Candidates must hold a life sciences qualification such as:
- B.Pharm
- M.Pharm
- Pharm.D
- M.Sc (Life Sciences, Pharmacology, Clinical Research)
- B.Sc (Life Sciences)
A strong academic background in pharmacology or clinical research will be advantageous. Senior Drug Safety Associate Job in Navi Mumbai at Clinexel CRO
Experience
- Minimum 3 years of relevant experience in pharmacovigilance or drug safety.
- Prior experience in ICSR case processing and safety database management is mandatory.
- Experience working in a CRO or pharmaceutical company environment is preferred.
Skills Required
- Thorough understanding of global pharmacovigilance regulations.
- Practical knowledge of MedDRA and WHO-DD coding systems.
- Familiarity with safety databases and case processing workflows.
- Strong documentation and compliance skills.
- Ability to work under timelines and manage multiple cases simultaneously.
- Effective communication and coordination skills.
Candidates must demonstrate accuracy, accountability, and regulatory compliance expertise. Senior Drug Safety Associate Job in Navi Mumbai at Clinexel CRO
Salary & Benefits
Salary will be offered as per company norms and based on candidate experience and skillset.
Professional Benefits May Include:
- Exposure to global pharmacovigilance projects.
- Experience with international safety reporting standards.
- Structured CRO workflows and compliance frameworks.
- Career growth opportunities in drug safety and risk management.
- Stable on-site professional working environment.
Selection Process
The recruitment process may involve:
- Resume shortlisting based on pharmacovigilance experience.
- Technical interview focusing on ICSR processing and regulatory knowledge.
- HR discussion covering role expectations and compensation.
- Final selection and offer communication.
Only shortlisted candidates will be contacted for further evaluation. Senior Drug Safety Associate Job in Navi Mumbai at Clinexel CRO
How to Apply
Interested and eligible candidates should send their updated CV to the official email address mentioned below:
Email: careers@clinexel-cro.com
Suggested Subject Line: Application – Sr Drug Safety Associate – Navi Mumbai
Applicants are advised to apply at the earliest, as senior pharmacovigilance roles are typically filled quickly. Senior Drug Safety Associate Job in Navi Mumbai at Clinexel CRO
Why Apply for This Drug Safety Job?
The pharmacovigilance sector continues to expand due to stricter regulatory requirements and increasing focus on patient safety. This opportunity offers:
- A senior-level role with greater responsibility in safety case management.
- Direct exposure to global regulatory frameworks.
- Career progression within pharmacovigilance and risk management domains.
- Experience in structured CRO-based safety operations.
- Long-term stability in a growing clinical research sector.
For professionals seeking to strengthen their expertise in ICSR processing, regulatory reporting, and aggregate safety documentation, this role provides meaningful growth and accountability. Senior Drug Safety Associate Job in Navi Mumbai at Clinexel CRO
Important Note
IndiaPharmaJobs.in is an independent job information platform sharing verified pharmaceutical and clinical research job opportunities across India. We are not affiliated with Clinexel CRO or any other company mentioned above. Candidates are advised to apply only through the official email provided and should never pay any recruitment fee. IndiaPharmaJobs.in does not charge any amount for job applications. Senior Drug Safety Associate Job in Navi Mumbai at Clinexel CRO
Final Call-to-Action
If you have at least three years of pharmacovigilance experience and are ready to advance into a senior drug safety role, apply now for the Senior Drug Safety Associate position in Navi Mumbai. Send your updated CV via email and take the next step in your pharmacovigilance career. Senior Drug Safety Associate Job in Navi Mumbai at Clinexel CRO
