08 Sep
|
Arkon Solution
|
Mulund West
08 Sep
Arkon Solution
Mulund West
Job Description: Medical Advisor
Role Overview
The Medical Advisor will play a critical role in ensuring patient safety, regulatory compliance, and medical governance across the organization. The primary responsibility of this role will be Pharmacovigilance activities, Adverse Drug Reaction (ADR) reporting, and medical advisory support.
In addition to the core responsibilities, the role will also support product authorization activities, imported medicines (including rare disease products), content development, and WHO GDP compliance, in close coordination with Sales, Marketing, Quality, Regulatory Affairs, and Leadership teams.
Key Skills & Competencies
- Robust knowledge of Pharmacovigilance regulations and drug safety reporting
- Sound understanding of medical, clinical, and regulatory requirements
- Experience in scientific training and cross-functional collaboration
- Excellent documentation, analytical, and communication skills
- Ability to manage multiple responsibilities and priorities
Educational Qualification
- M.Pharm / Pharm.D / MBBS / MD (Pharmacology or relevant specialty) (As per organizational requirement)
Primary Key Responsibilities
1. Pharmacovigilance (Primary Focus)
- Oversee and manage all Pharmacovigilance (PV) activities in compliance with national and international
- regulations.
- Establish, implement, and maintain PV systems and Standard Operating Procedures (SOPs).
- Ensure timely collection, assessment, processing, and documentation of safety data for marketed and
- investigational products.
- Coordinate with Regulatory Affairs for safety submissions, renewals, inspections, and audits.
- Participate in internal and external PV audits and ensure compliance.
- Conduct periodic safety reviews, signal detection, and risk assessment activities.
2. Medical Advisor Responsibilities (Primary Focus)
- Provide scientific and clinical guidance to internal teams.
- Review and approve promotional, marketing, and educational materials for medi
📌 Medical Advisor (Mulund West)
🏢 Arkon Solution
📍 Mulund West