We are currently seeking a Safety Associate I/II to support our work with Aggregate Reporting, Signal Management, and Risk Management Plans. Within the role you will:
- 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
Desirable Skills and Experience
- 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