Safety Specialist - II

Job Description

We are currently seeking a Safety Specialist II to support our work with Aggregate Reporting, Signal Management, and Risk Management Plans. Within the role you will:

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

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

Bangalore, India

Graduate or Post-Graduate degree in Life Sciences, Pharmacy, Medicine, Dentistry, Allied Health Sciences, and any other additional related courses

Analyst

Pharmacovigilance and Safety

Full Time

13 Jun 2022