Analyst - Drug Information & Risk Mgmt

Job Summary

Part of multi-disciplined team of healthcare professionals who support Apotex products (domestic and international) by 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.
• Demonstrates technical and scientific skills in the research and interpretation of medical information.
• Evaluates, analyzes and responds to medical inquiries in an accurate, balanced and timely manner.
• Creates 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.
• Updates/maintains product databases/files as required.
• Prepares educational materials which are part of Risk Minimization Measures.
• 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 DI&RM 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
  • B.Sc., or Diploma in Health/Science related discipline
  • Bachelor of pharmacy
• 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
  • Minimum 1-2 years of experience in pharmaceutical Indutry preferably in a Clinical, Pharmacovigilance, Medical Affairs or Regulatory role.