Medical Advisor – Vaf 173

5-7 years

Not Disclosed

Remote

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.

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Medical Advisor – Vaf 173

Job Description

Responsibilities:

Clinical Phase:

Post-Marketing (Pharmacovigilance):

Required Education:

Required Experience:

Required Technical Skills:

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