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Product Safety and Risk Management Project Leader

Date: Jan 15, 2022

Location: North York, ON, CA, M9L 2W6

Company: Apotex

 

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

 

 

Global Pharmacovigilance (GPV) is an operating department within Global Quality & Compliance of Apotex. The GPV department is involved in the processing and submission of adverse drug reaction reports production of periodic safety reports, signal detection and risk management to support the development and commercialisation of Apotex products in the markets in which we do business, in compliance with pharmacovigilance (PV) regulations & relevant ICH guidelines.

The Project Leader performs and provides peer review for the global pharmacovigilance processes: Literature review; Signal detection, Risk Management plans and Risk Evaluation and Mitigation Strategies for products developed and manufactured by Apotex. Contributes to drafting and review of aggregate reports for products developed and manufactured by Apotex, in compliance with global drug safety regulations and ICH Guidelines. Interacts with health professionals and consumers and affiliate offices during investigation of all case reports or safety reviews. Participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities.

Job Responsibilities

 

  • Schedules workloads (i.e. safety reports & projects) and assigns tasks to team to ensure deadlines are met.  Prioritizes workload
  • Prepares and medically reviews aggregate reports such as PBRER/PSUR, PADERs and CARs
  • Conducts signal management activities including preparation of Drug Safety Analysis Reports
  • Involved in the Risk Management and REMS process; drafts, reviews and contributes to risk minimization measures and educational materials
  • Reviews and contributes to safety sections of the reference safety information (RSI) for regions where Apotex has Marketing Authorizations
  • Takes the lead on PSRM literature review process and ensures literature reviews deadlines are met.
  • Takes the lead and assists in the preparation of departmental SOPS, GSOPs, GSUMs and Pharmacovigilance Agreements with national and international business partners Coaches/mentors staff in the collection & reporting of adverse drug reactions; the preparation of quality reports and other functional tasks.
  • Advises management and the Drug Safety Committee when product safety issues are identified.
  • Creates and reviews Drug Safety Reports as requested by Quality Operations team.
  • Evaluates and investigates issues/problems/non-compliance, proposes solutions and implements corrective action plans; informing and escalating as appropriate. Identify issues and develop root cause analysis.
  • Contributes to departmental strategy & objectives which support Global Pharmacovigilance.
  • Represent Apotex at key international meetings, liaising with industry counterparts to identify new strategies (i.e. Canadian Generic Pharmaceutical Association)
  • Communicates regularly with external customers (HCP, consumers, Regulatory Authorities) and internal customers as required when investigating an adverse drug reaction or responding to a complex safety enquiry.
  • Liaises regularly with Apotex affiliates, third-party partners and vendors to ensure compliance with the safety data exchange process and safety issues.
  • Acts autonomously in daily conduct of department and escalates issues to the next level when required.
  • Demonstrates leadership and works as a member of a team to achieve all outcomes related to product safety and risk management tasks .
  • Performs all work and demonstrate behaviors that exhibit and are in support of Apotex Corporate Values of Perseverance, Courage, Collaboration, and Passion. Demonstrates strong and visible support of Apotex values.
  • Performs all work in accordance with all established regulatory and compliance and safety requirements, ensuring compliance with GCP and ICH guidelines.
  • Takes initiative for career development and seeks guidance from senior management to enhance knowledge.
  • 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

 

  • MBBS, B.SC, M.Sc. in Medicine, Dentistry, Pharmacy, Nursing or related health sciences with training and education in Pharmacovigilance.
  • Minimum 6 years pharmaceutical experience in Pharmacovigilance role.
  • 1-2 years in a supervisory or team leader role preferred.
  • Knowledge of Drug Safety database systems, ARGUS, MedDRA.
  • Excellent time management skills, research skills & analytical skills.
  • Knowledge of international regulations (Health Canada, FDA, EMA etc), ICH guidelines, GMP and GCP documents related to Pharmacovigilance.
  • Aggregate report, RMP and REMS experience desirable.
  • Excellent organizational & interpersonal skills and experience with team environment.
  • Excellent oral/ written communication in English.

COVID-19 VACCINATION POLICY: In accordance with Apotex Inc. (“Apotex”) policy, as of November 15, 2021, all individuals entering a Canadian site (including but not limited to employees, visitors, contractors and agency workers) must be fully vaccinated against COVID-19 in accordance with the current government requirements.  Further, all employees must maintain all future booster vaccines as approved and recommended by Health Canada.  Accommodation from these requirements for reasons pursuant to the Ontario Human Rights Code, or any other applicable law (most commonly for medical and/or religious reasons) will be reviewed and considered by Apotex.

 

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.