Navitas Life Sciences is a technology-backed global clinical research organization, with over 1500 employees spread across 6 countries. Navitas provides end-to-end services and solutions for Life Sciences. We help our clients address their drug development needs by bringing together the capabilities of a full-service CRO, a technology-led life sciences services provider across clinical, regulatory and safety, and a life sciences big data services and analytics provider.
Post : Safety Specialist - II
Job Description
Aggregate Reporting
• Conduct the authoring and review of Aggregate Safety Reports (i.e. DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports) and any other aggregate reports as per the requirement of the project
• Review Aggregate Safety Data from the database and generate Line Listings (LL) and Summary Tabulations (ST) and include the LL and ST in the appropriate template.
• Analyze safety and regulatory data provided by the client and prepare complete Aggregate Reports according to the client’s requirements.
• Perform literature screening for inclusion of significant safety articles in the respective section of aggregate reports
• Compile benefit-risk evaluation sections provided by medical reviewers, as applicable.
• Ensure compliance with internal and external timelines
• Address comments from internal and external/client reviewer
• Finalize reports as per client requirements
• Participate in internal and external audits and inspections by clients and health authorities.
Signal Management and Risk Management Plans
• Conduct screening, data mining, and frequency tabulation for potential signals including signal estimation using appropriate signal detection tool as per the client requirement.
• Generate line listings and summary tabulations from Argus/client safety database.
• Draft Signal detection, validation, assessment, and benefit-risk analysis and prioritization of signals by reviewing available data.
• Ensure compliance to appropriate signal SOPs, conventions, and guidelines for all activities performed.
• Track identified signals from the regulatory and internal signal detection process and monitor the status of signals: potential signals, open signals, refuted signals, and validated signals.
• Develop Risk Management Plans and associated activities as per Navitas Life Sciences/client-specific SOPs
Candidate Profile
• Graduate or Post-Graduate degree in Life Sciences, Pharmacy, Medicine, Dentistry, Allied Health Sciences, and any other additional related courses
• Sound knowledge of the PV domain and working experience in Aggregate Reporting, Signal Management, and Risk Management Plans
• Good knowledge of DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports
• Excellent computer skills and knowledge of MS Office including Word, Excel, and PowerPoint
• Excellent organizational and time management skills
Additional Information
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmacovigilance and Safety
End Date : 25th July, 2022
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