ClinChoice is hiring for the position of Scientist / Senior Scientist – Aggregate Reporting in Bengaluru, Karnataka. The role focuses on preparing, reviewing, and managing aggregate safety reports for medicinal products, medical devices, and cosmetic products in compliance with global pharmacovigilance and regulatory requirements.
Candidates with a life sciences or healthcare-related degree and 3–6 years of relevant experience in aggregate reporting, drug safety, and regulatory guidelines can apply.
Job Details
| Particulars | Details |
|---|---|
| Company | ClinChoice |
| Job Title | Scientist / Senior Scientist – Aggregate Reporting |
| Location | Bengaluru, Karnataka, India |
| Experience | 3–6 years |
| Qualification | Bachelor’s or Master’s degree in Life Sciences or Healthcare |
| Job Category | Pharmacovigilance / Aggregate Reporting |
| Domain | Drug Safety & Regulatory Reporting |
Positions
- Scientist – Aggregate Reporting
- Senior Scientist – Aggregate Reporting
Job Responsibilities
Selected candidates will be responsible for the following activities:
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- Author aggregate safety reports, including PBRER/PSUR, DSUR, PADER, RMP, CAR, ACO, and ad-hoc safety reports.
- Prepare medical device safety reports, including EU-MDR PSUR, PMSR, PMSP, and PRER.
- Prepare cosmetovigilance reports for cosmetic products.
- Coordinate with stakeholders to collect safety data and contributions for aggregate reports.
- Review safety data, including seriousness and expectedness assessments of adverse events.
- Evaluate post-marketing safety cases and assess their impact on the product safety profile.
- Manage the complete report lifecycle, from drafting and review to approval and final release.
- Address review comments and ensure reports meet sponsor requirements.
- Support literature reviews and signal management activities.
- Conduct quality reviews of aggregate safety reports prepared by other team members.
- Monitor regulatory authority websites for safety updates, labelling recommendations, signal evaluations, and risk minimization measures.
- Ensure compliance with applicable global pharmacovigilance and regulatory guidelines.
Eligibility / Qualifications
Candidates must meet the following requirements:
- Bachelor’s or Master’s degree in Life Sciences, Healthcare, or an equivalent discipline.
- 3–6 years of relevant experience in the applicable domain.
- Good understanding of global regulatory requirements and drug safety.
- Thorough knowledge of pharmacovigilance and regulatory guidelines.
- Familiarity with drug safety case management.
- Knowledge of safety databases such as ARGUS and ARISg.
Required Skills
- Aggregate Safety Report Writing
- PBRER / PSUR Preparation
- DSUR and PADER Reporting
- Risk Management Plans (RMP)
- Pharmacovigilance and Drug Safety
- Signal Detection and Signal Management
- Literature Review
- Post-Marketing Safety Assessment
- Regulatory Compliance
- ARGUS and ARISg Safety Databases
- Quality Review and Report Validation
- Stakeholder Coordination
- Strong Written and Verbal Communication
Important Regulatory Guidelines
Candidates should be familiar with the following regulatory guidelines and requirements:
- GVP Modules V, VI, VII, and IX
- ICH E2C(R2)
- ICH E2F
- EU Medical Device Regulation (EU MDR)
- 21 CFR 314.80 / 600.80
- Health Canada GVP GUI-0102
