Senior Analyst, Drug Information & Risk Management

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 (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.