PV Scientist – Case Processing
Experience: 1–2 Years
Locations: Mumbai / Noida, India
Employment Type: Full-Time
Function: Pharmacovigilance / Drug Safety
Role Overview
We are seeking a PV Scientist – Case Processing to support end-to-end Individual Case Safety Report (ICSR) processing within a high-volume pharmacovigilance program focused primarily on over-the-counter (OTC) and consumer healthcare products.
This is an entry-level scientific role covering the complete ICSR lifecycle, from case intake and triage through data entry, coding, narrative writing, submission, and follow-up. Structured training will be provided to help develop strong pharmacovigilance and case processing expertise.
Qualification and Experience
Bachelor's or professional degree in Pharmacy, PharmD, BHMS, BDS, or an equivalent discipline preferred.
Minimum 6 months of relevant experience in:
Pharmacovigilance
Drug safety
Clinical research
Clinical or scientific operations
Other related safety domains
Candidates with limited experience but a strong scientific background may be considered for training-based opportunities.
Key Responsibilities
Case Intake and Triage
Perform case intake and book-in activities according to program-specific SOPs.
Conduct initial triage and validity assessment of safety cases.
Ensure cases meet established validity criteria before processing.
Identify cases requiring escalation based on seriousness or complexity.
Ensure cases are prioritized and processed within defined timelines.
ICSR Case Processing
Perform end-to-end Individual Case Safety Report (ICSR) processing.
Enter patient, reporter, product, event, and other relevant information accurately into the safety database.
Perform MedDRA coding of adverse events and relevant medical information.
Draft clear and accurate case narratives.
Ensure case information is complete, consistent, and aligned with source documentation.
Process cases according to project-specific procedures and quality requirements.
Regulatory Submission and Follow-Up
Manage E2B submissions in accordance with applicable requirements.
Conduct case follow-up activities when additional information is required.
Track follow-up requests and ensure appropriate documentation and updates.
Maintain accurate case records throughout the complete case lifecycle.
Quality and Compliance
Maintain high standards of accuracy and quality across all case processing activities.
Ensure compliance with SOPs, project requirements, regulatory standards, and established timelines.
Perform appropriate quality checks before case completion or submission.
Identify and escalate discrepancies, complex cases, and potentially serious cases appropriately.
Support timely resolution of quality findings and case-related issues.
Training and Development
Participate in structured training programs to strengthen pharmacovigilance knowledge and case processing capabilities.
Continuously develop expertise in ICSR processing, MedDRA coding, narrative writing, safety databases, and regulatory requirements.
Apply feedback from quality reviews and experienced team members to improve performance.
Contribute to team knowledge-sharing and process improvement activities.
Key Skills
End-to-end ICSR case processing.
Case intake and book-in.
Case triage and validity assessment.
ICSR data entry.
MedDRA coding.
Medical narrative writing.
E2B submissions.
Case follow-up management.
Pharmacovigilance and drug safety principles.
Quality and regulatory compliance.
Safety database experience, such as:
Argus
LSMV
Veeva
Equivalent pharmacovigilance safety databases
Good understanding of consumer healthcare and OTC products.
Strong attention to detail.
Good written and verbal communication skills.
Ability to work effectively in a high-volume, deadline-driven environment.
Ideal Candidate Profile
The ideal candidate is an early-career pharmacy, PharmD, BHMS, BDS, or related healthcare/science professional interested in building a career in pharmacovigilance and drug safety.
The candidate should have a strong interest in ICSR case processing, good attention to detail, and the ability to learn safety databases, MedDRA coding, narrative writing, and regulatory submission processes. Experience in consumer healthcare or OTC pharmacovigilance is an added advantage.
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