Senior Medical Reviewer-Pharmacovigilance Specialist

2 days ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,35,00,000
Job Description:

As a Medical Reviewer – Pharmacovigilance Specialist, you will be responsible for the comprehensive medical evaluation of individual case safety reports (ICSRs) to ensure compliance with regulatory and client-specific requirements.

You will play a critical role in safeguarding patient safety through high-quality medical assessment and regulatory reporting.

Key Responsibilities:
  • Perform thorough medical review of ICSRs for accuracy, medical relevance, and consistency with source documents and safety database entries, in alignment with client requirements.
  • Conduct second-level triaging of non-serious cases to identify any potential serious adverse events (SAEs), as per client-specific conventions.
  • Review and validate: Suspect product coding, Event selection and MedDRA coding, Grouping/subsuming and event ordering, Confirm and correct: Event coding and classification, Ranking of events, seriousness criteria, and listedness/expectedness
  • Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports.
  • Assess adverse events for seriousness, listedness, and causality, ensuring all medically relevant data from source documents is accurately reflected.
  • Review and enhance narratives in compliance with client conventions.
  • Provide or verify company pharmacovigilance (PV) comments as needed.
  • Initiate appropriate follow-up queries based on clinical context of the case.
  • Identify and escalate potential safety signals or concerns in line with client procedures.
  • Ensure completeness and medical soundness of cases before providing final medical sign-off.
  • Assess malfunctions and serious injury/death outcomes in relation to combination products.
  • Participate in literature surveillance and aggregate report medical review, ensuring compliance with regulatory timelines and SOPs.
  • Track and document inconsistencies in data entry and provide feedback for continuous improvement.
  • Collaborate closely with cross-functional teams to maintain scientific accuracy, clarity, and regulatory compliance in all case documentation.
  • Stay updated with international pharmacovigilance regulations and follow all applicable SOPs, guidelines, and best practices.
  • Attend mandatory internal and client-specific trainings to ensure continuous compliance.
Requirements:
  • Medical degree or equivalent experience in pharmacovigilance
  • Proven track record in medical review and pharmacovigilance
  • Strong analytical and problem-solving skills
  • Excellent communication and interpersonal skills
  • Ability to work in a team environment
Benefits:
  • Competitive salary and benefits package
  • Ongoing training and development opportunities
  • Collaborative and dynamic work environment
Others:
  • Opportunity to work on complex and challenging projects
  • Chance to make a meaningful contribution to patient safety
  • Flexible working arrangements

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