PV Physician-Medical Assessment

4 days ago

Hyderabad, India Dr Reddy's Laboratories Limited Full time
Job Description

Purpose:

PV is primarily responsible for the oversight of and provision of medical input to benefit-risk assessment activities including: ad hoc data analysis in support of internal/external queries; preparation and review of aggregate reports; signal detection and evaluation; support of benefit-risk evaluation efforts; generation and/or review of risk management plans (RMPs), risk evaluation and mitigation strategies (REMS), identification of risk minimisation measures; handling of responses to Regulatory Authority queries, scientific/medical input to other safety related documentation including Health Hazard Evaluations, clinical study protocols, final study reports, dossier documents, Medical Affairs activities, commercial/marketing information, as needed and providing support for product labelling activities.

Main Responsibilities:

  • Medical Review quality control (MRQC) of medical assessment of individual case safety reports (including coding, seriousness, expectedness, and company causality assessments) done by the vendor.
  • Provide medical input and/or review of aggregate reports including: PSUR, PBRER, PADER, DSURs and ACOs.
  • Conduct peer quality review of aggregate reports, and quality review of reports generated by the vendor.
  • Signal management activities for assigned products, ensuring signal detection is conducted in a regular, timely manner in accordance with signal management schedule.
  • Literature review for signal detection and validation.
  • Signal validation report preparation. 
  • Conduct aggregate safety data review on an ad hoc basis to support benefit-risk evaluations.
  • Author/review RMPs and aRMM activities as required
  • Prepare/review Health Hazard Evaluations and other ad hoc safety reports as requested.
  • Labeling document review: provide medical input to reference safety information, Investigator Brochures, product labels and patient information leaflets to ensure the most up to date and accurate safety information is present in all labeling information.
  • Regulatory Authority query management: liaise with Regulatory Affairs to respond to PV-related Regulatory Authority queries; coordinate with various stakeholders when finalizing the response, ensure responses are tracked to closure.
  • Participate in development of CAPA and take ownership of CAPA completion as assigned.
  • Participate in regular, scheduled meetings with PV team/service provider/third parties as required.
  • Support for PV QMS: Support the development and revision of department SOPs and work instructions. And participate in the review of cross-functional SOPs which include reference to PV activities.
  • Any other activity assigned by Global Head- Medical Assessment.

Relationship Management

  • Working within PV team and cross-functionally with key stakeholder functions including Clinical, Regulatory Affairs, Medical Affairs, Commercial Teams and Business Units.
  • Interactions with vendors/service providers for PV activities.

Process Improvement / Standardization

  • Participate in process improvement initiatives under supervision of Head of Medical Assessment and Global Head of Pharmacovigilance to promote internal audit and regulatory inspection readiness.

Qualifications

Educational qualification: MBBS with or without MD

0 to 3 years of relevant experience post MBBS or MD

Desired Skills & Competencies

  • Good working knowledge of PV regulations including FDA, EU & local requirements.
  • Good data analysis and report writing skills.
  • Excellent teamwork and interpersonal skills.


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