Medical Reviewer-Drug Safety Physician

Location: Bengaluru

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We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below:

Job Title:

Medical Reviewer – Pharmacovigilance

Location:

Work from office:  Bangalore, Hyderabad, Mumbai, Pune, Delhi
Willingness to relocate  to one of the above locations is mandatory and we are flexible.

Education Requirements:

MBBS/MD
Medical council of India registration ( Mandatory)

Job Description:

As a  Medical Reviewer – Pharmacovigilance , you will be responsible for the comprehensive medical review of individual case safety reports (ICSRs) and ensuring compliance with regulatory and client-specific requirements. You will play a critical role in safeguarding patient safety through high-quality medical evaluation and regulatory reporting.

Key Responsibilities:

Perform medical review of ICSRs for  accuracy ,  medical relevance , and  consistency  with the 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 (current version)
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 the 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.
Required Skills and

Competencies:

Strong  analytical and critical thinking  abilities
High  attention to detail  and scientific accuracy
Sound  medical judgment  and decision-making in line with pharmacovigilance standards
Proficiency in  medical…