Medical Reviewer – Aggregate Reports/Signal Management

Job Description

We are currently seeking a Medical Reviewer to support our work in Aggregate Reporting and Signal Management. Within the role you will:

  • Conduct the review and assessment of Individual Case Safety Reports (ICSRs) obtained from clinical trials, spontaneous, and solicited reports.
  • Determine regulatory reportability of cases obtained from clinical trials, spontaneous, and solicited reports within the assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
  • Perform triage of cases and determine seriousness and relatedness across products as assigned
  • Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, and review narrative.
  • Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
  • Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
  • Conduct an assessment of litigation cases across products as assigned
  • Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
  • Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
  • Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues
  • Prepare and review periodic aggregate safety reports
  • Support the preparation and maintenance of safety sections of the Company Core Data Sheet
  • Lead/support PDS post-marketing safety study activities
  • Carry out signal detection activities and evaluation
  • Follow up on reconciliation of discrepancies.
  • Perform literature review activities when trained and assigned.
  • Participation in local or global project teams, including on-time delivery of assigned responsibilities
  • Oversee, improve, and contribute to procedures and performance
  • Collaborate in the development, review, and initiation of SOPs
  • Interact with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects
  • Identify documents and appropriately resolve out-of-scope work as directed by senior management
  • Maintain a working knowledge of GCPs and regulatory requirements relating to clinical and PV teams to assure compliance with regulatory standards
  • Mentor other staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion, and integrity, support Senior Management’s leadership of both the department and the company
  • Read and acknowledge all necessary Navitas Life Sciences Standard Operating Procedures (SOPs) as required.
  • Execute administrative operational tasks as required
  • Provide oversight on operational activities and a sound understanding of project plans/documents
  • Participate in team meetings and provide regular feedback to the management on operational metrics and other challenges/issues

Desirable Skills and Experience

  • Sound knowledge of the PV domain and working experience with Risk Management Planning Reports, Signal Detection, and Evaluation, and the preparation and review of Periodic Aggregate Safety Reports
  • Excellent computer skills and knowledge of MS Office including Word, Excel, and PowerPoint
  • Excellent organizational and time management skills

Bangalore, India

MBBS or MD, completed a Board Certification and/or relevant higher medical training


Pharmacovigilance and Safety

Full Time

13 Jun 2022