Medical Reviewer-Drug Safety Physician

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Job Type

Full Time

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. 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:

Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate

Education Requirements:

  • MBBS and MD (mandatory)

  • Candidates without both qualifications will not be considered.


Job Title: Medical Reviewer – Pharmacovigilance

Location:

Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate


Education Requirements:

  • MBBS, MD(mandatory)

  • Medical council of India registration ( Mandatory)



Medical Reviewer – Pharmacovigilance

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.

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