Job Description

About Apotex Inc. Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

Job Summary

Prepares periodic safety update reports (PSURs/ PBRERs) in compliance with drug safety regulations and ICH Guideline. Utilizes best medical judgement in the analysis and evaluation of adverse reports, promptly resolving causality assessment queries and any other impreciseness in reporting by actively liaising with the reporting sites. Participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities.

Job Responsibilities

Primary responsibilities

• Prepares periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.
• Maintains current awareness of safety issues on Apotex products through ongoing monitoring & literature review demonstrating scientific skills in the research, analysis and interpretation of safety data.

• Prepares responses to slightly more complex queries, and requests for safety information from internal customer (RA, QA, NPD project teams etc.).
• 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.

Additional responsibilities

• Develops and maintains SOPs.
• Develops and maintains training documents and tracks compliance of internal and external global partners involved in drug safety reporting.
• Maintains user-level knowledge of Oracle ARGUS and MedDRA terminology.
• Works as a member of a team to achieve all outcomes.
• Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion.
• All other duties as assigned.

Supporting responsibilities

• May provide input and feedback to departmental process improvement strategy discussions.
• Contributes to the creation and promotion of an environment of teamwork ensuring excellence in customer service through the timely delivery of quality drug safety data.
• Liaises regularly and develops strong working relationship with external partners and international Apotex affiliates and demonstrates corporate values in the performance of work and in all interactions with others.
• Interacts with other internal departments when necessary.
• Contributes to interpretation of PV regulations and applies sound decisions related to regulatory guidelines and policies.
• Shows initiative to remain current on new PV regulations and international guidelines and seeks guidance from Group Leader and management to enhance knowledge.
• Performs all work in accordance with all established ICH guidelines, regulatory compliance and safety requirements and maintains current knowledge on all relevant Pharmacovigilance regulations.

Job Requirements

• Education
  • Physicians, Pharm.D, M Pharm, Nursing or related Health Science discipline
• Knowledge, Skills and Abilities
  • Excellent analytical and problem-solving skills
  • Excellent oral/written communication in English.
  • Knowledge of MedDRA, Oracle ARGUS & online literature searching preferred
  • Excellent organizational & interpersonal skills; experience in working in a dynamic team environment
  • Excellent knowledge of relevant local and international regulations and ICH guidelines on safety data management in clinical trials and post-approval
  • Advanced knowledge of Microsoft Office: Excel, PowerPoint, Word
• Experience

• • Core PV experience of at least 2-3 years\xe2\x80\x99 pharmaceutical experience
  • Periodic safety and risk management scientist: Preferred experience of at least 1-2 years on periodic reviews on aggregate safety data

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers 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.