Medical Reviewer-Drug Safety Physician

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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.

Education Requirements :

MBBS and MD (mandatory)

Candidates without both qualifications will not be considered.

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.

Education Requirements :

MBBS, MD(mandatory)

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 terminology

, disease pathology, pharmacology, and therapeutics

Ability to

analyze and interpret adverse event data

Strong

written and verbal communication skills

Good

comprehension

and the ability to

summarize complex medical data

Team player with effective

interpersonal and collaboration skills

Familiarity with

pharmaceutical industry practices

and

drug development processes

(preferred)

Additional Requirements :

Willing to relocate

to any of the listed office locations.

Ready to work from the office

with hybrid options

Must possess

MBBS and MD

degrees (non-negotiable)

EQUAL OPPORTUNITY :

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.