Job Description
Navitas Life Sciences are currently seeking a Safety Specialist II to support our work with Aggregate Reporting, Signal Management, and Risk Management Plans.
| Organization | Navitas Life Sciences |
| Post Name | Safety Specialist – II |
| Job Location | Bangalore |
| Official Website | https://www.navitaslifesciences.com/ |
Job Title/Position:
Safety Specialist – II
Job Overview:
Job vacancy for Life Sciences, Pharmacy, Medicine, Dentistry, Allied Health Sciences
Job Location
Bangalore, India
Key Responsibilities
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
What are the Educational Qualification(s) for this job?
Graduate or Post-Graduate degree in Life Sciences, Pharmacy, Medicine, Dentistry, Allied Health Sciences, and any other additional related courses
What are the Preferred Skills required for this job?
• 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.
Related:
ICGEB Recruitment 2022 Apply Online for Research Associate
Detailed notice
https://www.navitaslifesciences.com/careers/opportunities/60
