Job Title: Pharmacovigilance Safety Scientist
Company: ProPharma
Location: Bangalore, India
Work Model: Onsite / Hybrid
Job Type: Full-Time
Job ID: JR 7763
Experience Required: Minimum 2+ Years in Pharmacovigilance
About ProPharma
ProPharma is a leading global consulting organization that supports pharmaceutical, biotechnology, and medical device companies throughout the product lifecycle. For over two decades, ProPharma has delivered expert services across regulatory sciences, clinical research, pharmacovigilance, medical information, quality and compliance, and R&D technology. Through its comprehensive advise-build-operate model, the company enables organizations to accelerate drug development programs while ensuring compliance with global regulatory standards and patient safety.
Role Overview
The Pharmacovigilance Safety Scientist plays a key role within the Benefit-Risk group, supporting pharmacovigilance activities related to safety evaluation, aggregate report writing, and signal management. The role involves preparing regulatory safety documents, performing literature reviews, analyzing pharmacovigilance data, and ensuring compliance with global regulatory requirements. The Safety Scientist collaborates with senior pharmacovigilance professionals and leadership teams to deliver high-quality safety documentation within regulatory timelines.
Key Responsibilities
Aggregate Safety Report Authoring
Author and contribute to aggregate safety reports including Periodic Safety Update Reports (PSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), Periodic Adverse Drug Experience Reports (PADER), Development Safety Update Reports (DSUR), and Annual Reports.
Prepare Additional Clinical Overviews (ACO) and related regulatory safety documentation for submission to health authorities.
Risk Management and Signal Detection
Author and maintain Risk Management Plans (RMPs) as part of ongoing pharmacovigilance activities.
Prepare signal management reports and support safety signal evaluation processes.
Analyze pharmacovigilance data to identify emerging safety signals and potential risks.
Literature Review and Data Validation
Conduct literature searches and perform validity assessments for aggregate safety reporting.
Extract and validate safety data including Reference Safety Information (RSI), sales data, previous safety reports, and signal-related data.
Generate line listings from safety databases to support safety assessments.
Pharmacovigilance Operations Support
Reconcile pharmacovigilance process trackers and ensure accurate documentation.
Provide support for high-priority ad-hoc safety activities and regulatory requirements.
Ensure that all deliverables meet regulatory standards and client expectations within established timelines.
Quality and Compliance Management
Maintain compliance with global pharmacovigilance regulations including ICH-GCP, FDA, EMA, and other international regulatory guidelines.
Support the identification and documentation of deviations, CAPAs, and updates to standard operating procedures (SOPs) and work instructions.
Contribute to quality improvement discussions and pharmacovigilance performance metrics.
Cross-Functional Collaboration
Work closely with senior pharmacovigilance scientists, safety physicians, and management teams to support safety evaluation activities.
Collaborate with internal teams and clients to ensure effective pharmacovigilance processes and regulatory compliance.
Educational Qualifications
Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences, or another health-related discipline.
Experience Requirements
Minimum 2+ years of experience in pharmacovigilance operations.
Experience in medical writing, literature search, signal detection, or aggregate safety reporting.
Hands-on experience in literature screening and preparation or review of aggregate pharmacovigilance reports.
Required Skills and Competencies
Strong understanding of pharmacovigilance processes and global regulatory requirements.
Knowledge of ICH-GCP guidelines and international regulatory frameworks including FDA and EMA regulations.
Ability to analyze large datasets and summarize scientific findings in clear and concise medical documentation.
Excellent attention to detail with a strong focus on data accuracy and quality.
Strong analytical and problem-solving abilities.
Ability to work effectively within cross-functional and global teams.
Technical Skills
Proficiency in Microsoft Office applications including Word, Excel, and PowerPoint.
Experience working with pharmacovigilance safety databases and web-based applications.
Familiarity with pharmacovigilance documentation systems and safety reporting tools.
Work Environment
This role supports a hybrid work environment, allowing employees to collaborate both remotely and in office locations. ProPharma encourages in-person collaboration where feasible while maintaining flexibility for remote work arrangements.
Job Location
Bangalore, India.
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