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

Strong 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)

Act as the medical subject matter expert for company products. Provide scientific and clinical guidance to internal teams. Review and approve promotional, marketing, and educational materials for medical accuracy and compliance. Support product positioning, strategy development, and lifecycle management. Conduct scientific training and product knowledge sessions for Sales and Marketing teams. Respond to medical queries from healthcare professionals and internal stakeholders. Stay updated with clinical guidelines, medical literature, and therapeutic advancements.

3. Adverse Drug Reporting (Primary Focus)

Ensure accurate and timely ADR reporting to regulatory authorities as per prescribed timelines. Review, assess, and medically evaluate Individual Case Safety Reports (ICSRs). Coordinate follow-ups for adverse events with cross-functional teams. Maintain safety databases and documentation. Train internal teams on adverse event identification, reporting, and PV awareness. Monitor safety trends and escalate risks appropriately.

Additional Responsibilities (Secondary)

4. Product Authorization

Conduct scientific training for all products with exclusive authorization from suppliers. Support business strategy and appropriate product positioning in the Indian market. Design and implement a complete training calendar for the sales team.

5. Imported Medicines & Rare Diseases

Lead training sessions for imported products, with a focus on rare diseases and specialty therapies. Conduct in-depth market research on product ranges and emerging trends in rare diseases. Provide strategic insights and competitive intelligence to support business decisions. Share regular market research updates and trend analysis with the Leadership team. Design and maintain training calendars for the sales team.

6. Content Writing & SEO Support

Assist in creating SEO-optimized medical and scientific content for internal and external communication.

Collaborate with Marketing and Communications teams for LBLs, social media content, and digital assets.

Review, validate, and update existing website content for medical accuracy and compliance.

7. WHO GDP Compliance

Ensure adherence to WHO GDP principles and company GDP quality systems. Comply with WHO GDP SOPs (including SOP 12, 15, 18, and 24). Support quality risk identification and communicate findings to the Quality Manager. Participate in GDP audits and compliance-related activities as required.
Job Types: Full-time, Permanent

Pay: ₹45,000.00 - ₹55,000.00 per month

Benefits:

Health insurance Provident Fund
Application Question(s):

Are you based in Mumbai?
Work Location: In person