Sr Analyst, Drug Information & Risk mgmt

Apotex; Mumbai; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Apotex is seeking a Pharmacovigilance professional in Mumbai to support domestic and international products by coordinating medical documents and responding to inquiries from healthcare professionals and internal customers.

You will analyze medical information, update risk management plans, and ensure compliance with regulatory and safety requirements while collaborating with cross-functional teams.

Qualifications

• Bachelor of Pharmacy or higher or equivalent health/science degree.
• Pharmacovigilance experience is preferred (1–3 years).
• Strong communication and literature search skills.

Responsibilities

• Respond to medical inquiries from healthcare professionals and internal customers.
• Evaluate and respond to inquiries in a balanced and timely manner.
• Coordinate development of risk management plans and related medical documents.
• Maintain product databases and collaborate with cross-functional teams.
• Ensure compliance with regulatory and safety requirements.

Skills

Excellent communication

Oral and written communication

Team collaboration

Education

Bachelor of Pharmacy

Diploma/Sc. in Health/Science

Master of Pharmacy

Bachelor of Dental Surgery

Tools

ARISg Safety Database

MedDRA

Argus

Embase

MLM database

Job description

Job Summary

Part of multi-disciplined team of healthcare professionals who support Apotex products (domestic and international) by coordination of the development of medical documents such as Risk Management & Risk Evaluation Mitigation Plans, informing internal and external customers of the safe and effective use of drugs manufactured and marketed by Apotex Inc. and their affiliates/distributors worldwide by providing professional, unbiased, clinically relevant and timely medical information.

Job Responsibilities

• Provides verbal and written responses to medical inquiries from healthcare professionals, sales representatives and other internal customers on Apotex products.
• Evaluates, analyzes and responds to medical inquiries in an accurate, balanced and timely manner.
• Coordinates the preparation/updating of Risk Management & Risk Evaluation Mitigation Plans globally including input into the medical sections of them using relevant regional templates.
• Demonstrates technical and scientific skills in the research and interpretation of medical information.
• Creates and peer reviews new and revised medical information documents (eg response documents, recall QAs, bulletins, etc.)
• Participates in departmental and cross-functional business teams by supporting team initiatives and contributing directly or indirectly to team goals/projects based on priority to the business. Ensures compliance with all SOPs pertaining to adverse event and quality complaint reporting.
• Maintains awareness of current therapeutics and industry-based medical information regulations.
• Provides on-call coverage as per schedule
• Assists in the preparation of reports
• Updates/maintains product databases/files as required.
• Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Perform all other duties and special projects and after-hour coverage of DISPedia unit as assigned.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Bachelor of Pharmacy.
  • Sc., or Diploma in Health/Science related discipline
  • Master of Pharmacy
  • Bachelor of Dental Surgery
• Knowledge, Skills and Abilities
  • Excellent oral/written communication skills.
  • Knowledge of Microsoft Office software: Excel, PowerPoint, Word, Outlook, etc.
  • Knowledge of Arisg Safety Database, MedDRA and Argus
  • Knowledge of Embase and MLM database
  • Knowledge of online literature searching and review.
• Experience
  • 1-3 years of experience in Pharmacovigilance.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.