05 Nov
|
Gratitude
|
Bengaluru
05 Nov
Gratitude
Bengaluru
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.
- Solid 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.
📌 Medical Reviewer (Bengaluru)
🏢 Gratitude
📍 Bengaluru