Job Summary

We are looking for a qualified MBBS doctor with at least 2 years of clinical and/or Pharmacovigilance experience to join our Life Sciences team as a Medical Reviewer. The role involves medical review of adverse-event cases, assessment of drug safety information, causality evaluation, and ensuring compliance with applicable safety procedures and regulatory timelines.

Key Responsibilities

• Medically review clinical, solicited, spontaneous, and literature adverse-event cases.

• Perform medical assessments, including product labeling and causality assessments.

• Review case seriousness, medical coding, and overall medical consistency.

• Evaluate case narratives, adverse-event and serious adverse-event terms, suspect drugs, concomitant medications, laboratory results, and medical history.

• Maintain knowledge of relevant diseases and safety concerns associated with marketed and developmental drugs.

• Provide medical guidance to Drug Safety teams to support accurate, high-quality adverse-event processing.

• Review and respond to queries or comments related to Individual Case Safety Reports (ICSRs).

• Generate, send, and track medically relevant follow-up queries.

• Provide medical advice for cases involving suspected unexpected serious adverse reactions (SUSARs).

• Represent the Safety Physician team during internal and client safety meetings and audits.

• Ensure compliance with regulatory timelines, standard operating procedures (SOPs), and applicable client procedures.

Mandatory Qualifications

• MBBS or equivalent medical qualification.

• Minimum 2 years of clinical and/or Pharmacovigilance experience.

• Strong medical knowledge and the ability to apply clinical expertise to drug safety assessments.

• Understanding of Pharmacovigilance, drug safety, and regulatory processes.

Required Skills

• Medical review and clinical assessment.

• Adverse-event case review and drug safety evaluation.

• Medical decision-making and problem-solving.

• Knowledge of causality assessment and case seriousness.

• Strong written and verbal communication.

• Ability to prioritize tasks and work in a multidisciplinary team.

• Proficiency in MS Office and general computer applications.

Job Details

• Domain: Life Sciences

• Locations: Mumbai and Bangalore

• Work Mode: Work from Office (WFO)

• Schedule: General Shift

Important Eligibility Criteria

• Ex-TCS employees are not eligible to apply.

• PAN and date of birth (DOB) are mandatory for profile creation.