Pharmacovigilance Scientist, Aggregate Reports

Location

Secunderabad | India

Job description

ProPharma Group is looking for Pharmacovigilance Scientist, Aggregate Reports to join our dynamic team and embark on a rewarding career journey

• A Pharmacovigilance Scientist specializing in Aggregate Reports plays a crucial role in ensuring the safety of pharmaceutical products by monitoring and assessing adverse events associated with these products
• The job description may include the following responsibilities:Aggregate Report Preparation:Compile and prepare periodic aggregate safety reports, such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs)
• Ensure the accurate and timely submission of these reports to regulatory authorities in compliance with applicable regulations
• Signal Detection and Evaluation:Collaborate with cross-functional teams to identify potential safety signals by analyzing individual case safety reports (ICSRs), literature, and other relevant data sources
• Evaluate and assess safety signals to determine their significance and impact on the benefit-risk profile of the product
• Risk Management Activities:Contribute to the development and implementation of risk management plans for products, including Risk Evaluation and Mitigation Strategies (REMS) where applicable
• Monitor and evaluate the effectiveness of risk minimization measures
• Data Analysis and Interpretation:Conduct in-depth analysis of safety data, ensuring consistency and accuracy in interpretation
• Collaborate with statisticians and other relevant stakeholders to analyze safety data trends and patterns
• Literature Review and Surveillance:Stay abreast of scientific literature and publications related to the safety of assigned products
• Conduct ongoing literature surveillance to identify relevant safety information
• Regulatory Compliance:Ensure compliance with global pharmacovigilance regulations and guidelines in the preparation and submission of aggregate safety reports
• Respond to regulatory queries and requests related to safety information
• Cross-functional Collaboration:Collaborate with internal departments such as clinical development, regulatory affairs, and medical affairs to ensure a comprehensive understanding of safety data and its implications
• Participate in safety-related discussions and decision-making processes
• Quality Assurance:Contribute to the development and implementation of quality assurance processes within the pharmacovigilance function
• Participate in internal and external audits related to aggregate reporting
• Training and Development:Stay informed about changes in pharmacovigilance regulations and industry best practices
• Provide training and guidance to other team members as needed
• Documentation and Record Keeping:Maintain accurate and up-to-date documentation related to pharmacovigilance activities
• Ensure proper record-keeping of safety data and reports

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