Pharmacovigilance Safety Scientist
Company: ProPharma
Location: Bangalore, India
Job Type: Full-Time
Experience: Typically 2+ Years (Pharmacovigilance / Medical Writing / Signal Detection)
Qualification: Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences or related field
Salary Range: Not Specified
Job Overview
ProPharma is hiring a Pharmacovigilance Safety Scientist responsible for supporting benefit-risk and safety evaluation activities within pharmacovigilance operations.
The role involves authoring aggregate safety reports, managing signal detection activities, performing literature reviews, and ensuring compliance with global regulatory requirements. The PV Safety Scientist will collaborate with cross-functional teams, contribute to safety data analysis, and ensure timely and high-quality delivery of pharmacovigilance outputs.
Key Responsibilities
Aggregate Report Authoring
Prepare and author aggregate safety reports including PSURs, PBRERs, PADERs, DSURs, and Annual Reports.
Develop Risk Management Plans (RMPs) and signal management reports.
Ensure reports meet regulatory submission requirements.
Signal Detection & Safety Analysis
Perform literature searches and validity checks for safety data.
Analyze safety signals and contribute to signal management activities.
Extract and validate data from multiple sources including safety databases.
Data Management & Reporting
Generate line listings from safety databases.
Reconcile process trackers and ensure data accuracy.
Support ad-hoc safety data analysis and reporting tasks.
Quality & Compliance
Ensure compliance with global regulations such as ICH-GCP, FDA, and EMA guidelines.
Maintain high-quality standards in all deliverables.
Support SOP and WI updates, deviations, and CAPA documentation.
Cross-Functional Collaboration
Coordinate with senior PV scientists and management teams.
Work in a matrix environment with internal and client stakeholders.
Participate in discussions related to quality and performance metrics.
Documentation & Communication
Prepare clear, concise, and scientifically accurate medical documents.
Summarize complex medical data into meaningful insights.
Ensure timely submission of deliverables to clients.
Required Skills
Pharmacovigilance Expertise
Knowledge of aggregate report writing and safety reporting processes.
Understanding of signal detection and risk management activities.
Familiarity with global pharmacovigilance regulations.
Technical Skills
Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Experience with safety databases and data extraction.
Ability to handle large datasets and perform analysis.
Analytical & Problem Solving
Strong analytical and critical thinking skills.
Ability to interpret safety data and identify trends.
Communication
Excellent written and verbal communication skills.
Ability to write clear and scientifically accurate medical content.
Operational Skills
Strong organizational and time management skills.
Ability to manage multiple tasks within deadlines.
Basic Qualifications
Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences or related field
Minimum 2 years of experience in pharmacovigilance
Experience in medical writing, literature search, or signal detection
Preferred Competencies
Experience in aggregate report authoring and review
Knowledge of regulatory submission requirements
Experience in literature screening and safety data analysis
Key Competencies
Pharmacovigilance and safety evaluation
Aggregate report writing and signal detection
Regulatory compliance and documentation
Data analysis and interpretation
Cross-functional collaboration
About the Company
ProPharma is a global consulting organization providing regulatory, clinical, quality, pharmacovigilance, and R&D technology solutions to pharmaceutical, biotechnology, and medical device companies. The company supports clients across the product lifecycle, helping accelerate development and ensure compliance with global regulatory standards.
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