Job Title:
Pharmacovigilance Safety Scientist
Location: India
Job Type: Full-time
Job Requisition ID: JR 7763
Posted: 24 Days Ago
About ProPharma:
For over 20 years, ProPharma has been improving the health and wellness of patients by providing expert consulting services to pharmaceutical, biotech, and medical device companies. Through its advise-build-operate model, ProPharma offers customizable end-to-end solutions across the full product lifecycle in areas including:
Regulatory Sciences
Clinical Research
Quality & Compliance
Pharmacovigilance
Medical Information
R&D Technology
Job Summary:
The Pharmacovigilance (PV) Safety Scientist supports the Benefit-Risk group in day-to-day operations, ensuring timely and compliant execution of key pharmacovigilance deliverables. The role involves close collaboration with directors, managers, and senior PV scientists to maintain quality standards and deliverables.
Key Responsibilities:
Medical Writing & Aggregate Reports
Author aggregate reports such as:
PSURs / PBRERs
PADERs / Annual Reports / ACOs
DSURs
Prepare Risk Management Plans (RMPs).
Write Signal Management Reports.
Data Handling & Reporting
Perform literature searches and validity checks for aggregate reports.
Generate and validate line listings from the safety database.
Extract and validate data from:
RSI (Reference Safety Information)
Sales data
Previous safety reports
Risk Management Plans
Signal documentation
Process Management
Reconcile relevant process trackers.
Provide support for ad-hoc high-priority PV activities.
Ensure all deliverables to clients meet regulatory requirements and are submitted on time.
Compliance & Quality
Follow ICH-GCP, FDA, EMA, and other global regulatory standards.
Identify and author SOPs, work instructions (WIs), deviations, and CAPAs.
Contribute to quality discussions and metric compilation internally and with clients.
Required Skills & Abilities:
Strong analytical and problem-solving capabilities.
High level of attention to detail and quality focus.
Excellent organizational and communication skills.
Ability to collaborate in a team-based and matrixed environment.
Ability to analyze large datasets concisely and accurately for regulatory deadlines.
Experience in writing clear, concise, and unambiguous medical text.
Proficiency in MS Office and web-based applications.
Understanding of global PV regulations and compliance standards.
Education Requirements:
Bachelor’s or Master’s degree in:
Pharmacy
Nursing
Life Sciences
Other health-related fields, or equivalent work experience.
Experience Requirements:
Minimum 2+ years in Pharmacovigilance, with emphasis on:
Medical writing
Literature search
Signal detection
Experience contributing to metrics compilation, quality discussions, and report authoring/review.
Diversity & Inclusion Statement:
At ProPharma, we are committed to fostering a diverse, inclusive, and equitable workplace where all employees can be their authentic selves. We celebrate differences and provide a supportive environment that empowers everyone to succeed.
Additional Information:
No unsolicited resumes from recruiters or third-party agencies will be accepted.
Please refrain from phone calls or emails regarding this job posting.
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