2COMS is hiring experienced Pharmacovigilance professionals in Mumbai for ICSR Case Processing Associate (SPE) and Quality Review Associate (SME) positions.
This opportunity is suitable for graduates and postgraduates from Pharmacy, Life Sciences, Medical Sciences, and related disciplines who have hands-on experience in ICSR case processing, pharmacovigilance quality review, Argus Safety, or Veeva Safety.
Candidates selected for these Pharmacovigilance jobs will work across drug safety activities including case data entry, narrative writing, medical and product coding, case quality checks, serious case review, and quality improvement.
Available Positions
1. Case Processing Associate (SPE)
Experience Required: 1–2 years in Pharmacovigilance/ICSR Case Processing.
Key Responsibilities
- Perform end-to-end ICSR case processing and safety data entry
- Prepare and review case narratives
- Perform medical and product coding
- Handle case routing, unblinding, and case closure
- Conduct self-QC and other quality checks
- Work with USPI labeling requirements
- Maintain case processing accuracy and quality standards
2. Quality Review Associate (SME)
Experience Required: 2+ years in Pharmacovigilance/Quality Review.
Key Responsibilities
- Perform QC and post-lock review of safety cases
- Review serious and fatal adverse event cases
- Identify errors and monitor case-processing quality
- Provide feedback to Pharmacovigilance case processing teams
- Support quality improvement initiatives
- Ensure safety cases meet established quality requirements
Qualifications
Candidates should have a Graduate or Postgraduate degree in Life Sciences, Pharmacy, Medical Sciences, or a related discipline.
Relevant qualifications may include:
- B.Pharm / M.Pharm
- Pharm.D
- B.Sc / M.Sc in Life Sciences
- Biotechnology
- Microbiology
- Biochemistry
- Biomedical Sciences
- Medical Sciences
- Other closely related Life Science disciplines
The employer’s description specifies a Graduate/Postgraduate qualification in Life Sciences, Pharmacy, Medical Sciences, or related fields. Candidates should verify their individual eligibility during the application process.
Skills Required
Candidates should have relevant experience or knowledge in:
- Pharmacovigilance
- ICSR Case Processing
- Drug Safety
- Argus Safety
- Veeva Safety
- Narrative Writing
- Medical Coding
- Product Coding
- Case Quality Review
- Quality Control (QC)
- Serious and Fatal Case Review
- Case Closure
- USPI Labeling
- Quality Monitoring
- Analytical Skills
- English Communication Skills
Experience Required
For the Case Processing Associate (SPE) position, candidates should have approximately 1–2 years of Pharmacovigilance or ICSR case processing experience.
For the Quality Review Associate (SME) position, candidates should have 2+ years of Pharmacovigilance or Quality Review experience.
Experience working with Veeva Safety and/or Oracle Argus Safety is specifically preferred.
Benefits
According to the job information, selected candidates can expect:
- Career growth opportunities
- Exposure to global Pharmacovigilance processes
- Experience in ICSR case processing and quality operations
- Opportunity to strengthen drug safety and case review expertise
How to Apply
