ClinChoice Hiring Senior Scientist – Aggregate Reporting in Bengaluru
ClinChoice invites applications for the Senior Scientist – Aggregate Reporting position in Bengaluru, Karnataka. This opportunity suits experienced pharmacovigilance, drug safety, and medical writing professionals with expertise in aggregate safety reporting, safety data interpretation, and regulatory documentation. The role involves preparing and reviewing safety reports, evaluating benefit-risk information, and supporting global pharmacovigilance activities for consumer health products.
Company Overview
ClinChoice provides clinical development and consulting services to the pharmaceutical, biotechnology, and medical device industries. Its work supports drug development, clinical research, regulatory activities, and other services across the product life cycle.
Job Details
| Job Information | Details |
|---|---|
| Company | ClinChoice |
| Position | Senior Scientist – Aggregate Reporting |
| Department | Pharmacovigilance / Drug Safety |
| Location | Bengaluru, Karnataka, India |
| Experience | 8–10 years |
| Qualification | Advanced degree in a relevant scientific discipline |
| Employment Type | Refer to the official listing |
| Job ID | 4955679101 |
Job Role and Responsibilities
The Senior Scientist will prepare, review, and maintain pharmacovigilance and risk management documents using safety information from clinical studies, post-marketing surveillance, scientific literature, and other sources. The role requires strong scientific interpretation, medical writing, and knowledge of global safety reporting requirements.
1. Pharmacovigilance and Medical Writing
- Prepare, review, and maintain pharmacovigilance and risk management documents for consumer health products.
- Consolidate safety information from Individual Case Safety Reports (ICSRs), clinical trials, post-marketing surveillance, epidemiological studies, published literature, and signal detection activities.
- Draft and review Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), and Development Safety Update Reports (DSURs).
- Prepare aggregate safety reports, ad hoc safety reports, signal assessment reports, safety narratives, and risk management documentation.
- Support health authority responses and safety sections of regulatory submissions.
- Prepare safety surveillance reports, presentations, and analyses for Safety Management Teams.
2. Safety Data Analysis and Interpretation
- Collaborate with safety scientists, medical reviewers, and cross-functional teams to evaluate emerging safety information.
- Interpret safety trends, potential safety signals, and benefit-risk considerations.
- Review scientific literature and summarize relevant findings for pharmacovigilance activities.
- Contribute to evidence-based safety conclusions and recommendations.
- Support the analysis and review of risk management activities and reports.
3. Quality and Regulatory Compliance
- Ensure safety documents comply with applicable global pharmacovigilance regulations, company standard operating procedures, and relevant guidance.
- Maintain scientific accuracy, consistency, clarity, grammar, and overall document quality.
- Conduct quality control reviews and ensure assigned deliverables meet project timelines.
- Support audit and inspection readiness through accurate and complete documentation.
4. Cross-Functional Collaboration
The role involves working with Drug Safety, Medical Affairs, Regulatory Affairs, Clinical Development, Quality, and Research and Development teams. The successful candidate must communicate complex safety findings clearly and coordinate deliverables across multiple stakeholders.
This is an individual contributor position with no direct reports.
Eligibility Criteria
Candidates should meet the following educational and professional requirements.
Educational Qualification
An advanced degree is required in a relevant scientific discipline. Accepted qualifications listed by the employer include:
- PharmD
- PhD
- MD
- MPH
- MS
- Equivalent qualification in a relevant scientific discipline
Experience Requirements
- 8–10 years of experience in pharmacovigilance, drug safety, medical writing, regulatory writing, or a related field.
- Experience preparing pharmacovigilance and safety documents is preferred.
- Familiarity with global pharmacovigilance regulations and safety reporting requirements.
- Experience working in a cross-functional, matrixed environment with multiple stakeholders.
Key Skills Required
Candidates should demonstrate strong technical knowledge and scientific communication skills, including:
- Aggregate safety reporting and pharmacovigilance documentation
- PSUR, PBRER, PADER, and DSUR preparation or review
- Signal detection and safety signal evaluation
- Benefit-risk assessment
- Clinical research methodologies
- Epidemiology and biostatistics
- Evidence-based medicine
- Scientific literature evaluation
- Safety data interpretation
- Medical writing, editing, and proofreading
- Regulatory and scientific communication
- Quality control and compliance documentation
- Project management and deadline management
- Strong analytical, critical-thinking, and communication skills
How to Apply
Interested and eligible candidates can review the complete job description and submit their applications through ClinChoice’s official recruitment portal.
Apply Online: ClinChoice Senior Scientist – Aggregate Reporting
Applicants should review the employer’s requirements carefully and ensure their application accurately reflects their qualifications, aggregate reporting experience, and pharmacovigilance expertise.
Job Summary
| Category | Details |
|---|---|
| Company | ClinChoice |
| Department | Pharmacovigilance / Drug Safety |
| Position | Senior Scientist – Aggregate Reporting |
| Qualification | PharmD, PhD, MD, MPH, MS, or equivalent scientific degree |
| Experience | 8–10 years |
| Location | Bengaluru, Karnataka |
| Key Skills | Aggregate reporting, medical writing, safety data analysis, benefit-risk assessment |
| Job ID | 4955679101 |
| Apply Mode | Online |