Senior Analyst, Drug Information & Risk Management

APOTEX; Mumbai; On-site; INR 800,000 - 1,200,000; Full time

Benefits offered by this job

Disability accommodation

Interview accommodations

Job summary

APOTEX, a Canadian-based global health company, seeks a Pharmacovigilance professional in Mumbai to manage medical inquiries, safety data, and risk management tasks. The candidate should have 1–3 years of PV experience and strong communication skills.

You will collaborate with global teams to maintain safety databases, support regulatory submissions, and ensure compliance with safety standards. Accommodation in recruitment is available.

Qualifications

• Bachelor-level pharmacy degree or related health science qualification
• Strong written and verbal communication skills
• Experience in pharmacovigilance or medical information is desirable

Responsibilities

• Respond to medical inquiries from healthcare professionals and internal customers
• Evaluate and respond to medical inquiries accurately and timely
• Assist in the preparation/update of Risk Management Plans and safety documents
• Maintain awareness of therapeutics and regulatory safety requirements
• Support reporting and documentation processes in PV projects
• Collaborate with cross-functional teams to meet safety requirements and deadlines
• Provide on-call coverage as scheduled and assist in reports preparation

Skills

Excellent communication

Microsoft Office

Arisg Safety Database

MedDRA

Argus

Embase

Literature search

Pharmacovigilance experience

Education

Bachelor of Pharmacy

Sc., or Diploma in Health/Science related discipline

Master of Pharmacy

Bachelor of Dental Surgery

Tools

ARISg Safety Database

MedDRA

Argus

Job description

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Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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 (e.g. 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.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

For any inquiries regarding this posting, please contact: [e-mail]