Pharmacovigilance Safety Scientist
Company: ProPharma Group
Location: Bangalore
Work Model: Onsite / Hybrid
Employment Type: Full-time
Experience Required: 2+ Years
Salary (India Estimate): ₹8 LPA – ₹15 LPA
Job Overview
ProPharma Group is seeking a Pharmacovigilance (PV) Safety Scientist to support the Benefit-Risk group in managing pharmacovigilance operations and regulatory reporting activities.
In this role, you will contribute to drug safety monitoring, aggregate safety report writing, signal detection, and regulatory compliance, ensuring that pharmacovigilance deliverables meet global regulatory standards and timelines.
Key Responsibilities
Author aggregate safety reports such as PSURs/PBRERs, PADERs, Annual Reports, ACO, and DSURs for regulatory submissions.
Prepare and maintain Risk Management Plans (RMPs) as part of pharmacovigilance activities.
Draft Signal Management Reports to evaluate potential drug safety signals.
Perform literature searches and validity checks for pharmacovigilance reporting.
Extract and validate safety-related data including Reference Safety Information (RSI), sales data, previous reports, and safety signals.
Generate Line Listings (LL) from safety databases.
Maintain process trackers and perform reconciliation of pharmacovigilance data.
Support high-priority ad-hoc pharmacovigilance activities when required.
Required Skills
Strong analytical and problem-solving abilities.
Excellent attention to detail and quality-focused mindset.
Knowledge of global pharmacovigilance regulations including ICH-GCP, FDA, and EMA guidelines.
Ability to analyze large volumes of safety data and summarize findings clearly.
Strong medical writing skills for preparing regulatory documents.
Experience working in global or matrix team environments.
Familiarity with SOPs, deviations, CAPAs, and pharmacovigilance quality processes.
Proficiency with Microsoft Office (Word, Excel, PowerPoint) and web-based applications.
Educational Qualifications
Bachelor’s or Master’s degree in:
Pharmacy
Nursing
Life Sciences
Other health-related fields
Experience Requirements
2+ years of experience in Pharmacovigilance.
Experience in medical writing, literature search, or signal detection.
Experience contributing to aggregate safety reports or literature screening.
Exposure to pharmacovigilance metrics, reporting quality, and client discussions.
Benefits
Employees at ProPharma Group may receive:
Competitive salary and performance incentives
Health insurance coverage
Hybrid/remote work flexibility (based on location)
Career development and training opportunities
Inclusive and diverse workplace culture
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