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Medical Advisor – Vaf 406

10 years
Not Disclosed
10 Sept. 4, 2025
Job Description
Job Type: Remote Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Team Lead / Manager / Senior Medical Advisor / Reviewer – Clinical & Post-Marketing Drug Safety

Position Overview

We are seeking a highly experienced medical professional to lead and manage clinical and post-marketing drug safety activities. The ideal candidate will bring strong expertise in medical monitoring, pharmacovigilance, team leadership, and client communications, with proven ability to ensure compliance with global regulatory requirements.


Key Responsibilities

Clinical Phase (Medical Monitoring)

  • Act as Medical Monitor / Medical Expert for clinical studies.

  • Provide medical monitoring support, including:

    • Communication with clients and study sites.

    • Attending investigator meetings.

    • Addressing queries related to protocol or drug interactions.

  • Review and provide feedback on study protocols.

  • Draft and ensure compliance with Medical Monitoring Plans (MMPs).

  • Review adverse events (AEs), assess severity, and recommend appropriate actions (dose adjustment, discontinuation, etc.).

  • Assess SUSAR (Suspected Unexpected Serious Adverse Reaction) reportability.

  • Interpret and review clinical data, ensure protocol compliance, and prepare monthly client reports.

  • Deliver therapeutic area training for case processing teams.

  • Develop and update training materials in line with GCP and GVP requirements.

  • Provide 24/7 availability as needed for urgent protocol deviations or patient safety concerns.

Post-Marketing (Pharmacovigilance)

  • Lead and mentor medical reviewers in pharmacovigilance activities.

  • Conduct medical review of ICSRs (spontaneous, literature).

  • Support causality assessment, medical evaluation, and benefit-risk analysis of medicinal products.

  • Provide secondary reviews to ensure competency and quality.

  • Organize ongoing workshops and provide feedback for reviewer development.

  • Participate in audits and inspections as required.

  • Ensure client needs, conventions, and expectations are consistently met or exceeded.


Education

  • MBBS or MD (Doctor of Medicine) required.


Experience

  • Minimum 10 years in pharmaceutical industry or service providers.

  • At least 5–7 years as a Medical Monitor in clinical phase.

  • Proven experience leading medical review teams.

  • Strong track record of client communications.

  • Hands-on experience with safety databases and pharmacovigilance systems.


Technical & Professional Skills

  • Strong understanding of pharmacovigilance principles, GVP, GCP, FDA, and global regulatory requirements.

  • Expertise in adverse event reporting and causality assessment.

  • Working knowledge of EDC systems.

  • Proficiency in Microsoft Office Suite.

  • Solid background in medical science and pharmacology.