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Medical Advisor – Vaf 173

5-7 years
Not Disclosed
10 March 19, 2025
Job Description
Job Type: Full Time Education: MBBS/MD 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

Medical Advisor – VAF 173
Location: India (Remote Work Possible)
Department: Life Cycle – Safety and Vigilance
Contract Type: Permanent

Responsibilities:

Clinical Phase:

  • Act as a Medical Monitor/Medical Expert.
  • Provide medical monitoring and effectively communicate with clients, attend investigator meetings, and offer support to sites regarding protocol and possible drug interactions.
  • Review and provide feedback on study protocols.
  • Deliver therapeutic area training for case processing teams.
  • Ensure 24/7 availability depending on client needs to address protocol deviations or potential harm to patients.
  • Draft Medical Monitoring Plans (MMP) and ensure compliance.
  • Review adverse events (AEs) reported by study sites, assess severity, and determine appropriate actions such as dose adjustments or trial discontinuation.
  • Assess SUSAR reportability.
  • Review and interpret clinical data, ensure protocol compliance, and prepare monthly client reports, with presentations during periodic meetings if required.
  • Develop and update training materials aligned with GCP and GVP requirements for medical review.

Post-Marketing (Pharmacovigilance):

  • Lead the medical review team.
  • Conduct medical review of Individual Case Safety Reports (ICSRs) from spontaneous sources and literature.
  • Support causality assessments, medical evaluation, and benefit-risk assessments of medicinal products.
  • Mentor junior medical reviewers and perform additional reviews to ensure competency.
  • Provide feedback and conduct ongoing workshops for medical reviewers.
  • Participate in audits and inspections as required.
  • Understand client needs, adhere to conventions, and ensure expectations are met and exceeded.
  • Train and mentor other team members.

Required Education:

  • MBBS or MD (Doctor of Medicine)

Required Experience:

  • Proven experience in leading medical review teams.
  • Strong client communication skills.
  • Hands-on experience with safety databases.
  • Minimum of 10 years’ experience in the pharmaceutical industry or with service providers.
  • At least 5-7 years of experience as a Medical Monitor or in the clinical phase.

Required Technical Skills:

  • Proficiency in Microsoft Office Suite.
  • Strong understanding of pharmaceutical regulations including GVP, GCP, FDA, and drug safety requirements.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.
  • Working knowledge of Electronic Data Capture (EDC) systems.
  • Strong medical knowledge and understanding of pharmacology.