Medical Reviewer

Job Description

We are currently seeking a Medical Reviewer to assist in activities requiring clinical or post-marketing pharmacovigilance service lines. Within the role you will:

  • Conduct the review and assessment of individual case safety reports 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 and sites as necessary
  • 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 labelling, review narrative.
  • Acquire and maintain current knowledge of the 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 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, document and appropriately resolve out-of-scope work as directed by senior management
  • Maintain 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 standard operating procedures as required.
  • Execute administrative operational tasks as required
  • Provide oversight on operational activities and sound understanding on 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 in life cycle safety services
  • Good knowledge of Clinical and PV Drug Safety procedures and regulations
  • Excellent computer skills and knowledge of MS Office including Word, Excel, and PowerPoint
  • Excellent organizational and time management skills

Bangalore, India

MBBS or MD Pharmacology


Pharmacovigilance and Safety

Full Time

31 Jan 2022