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Manager, Safety Surveillance

Date: Apr 1, 2021

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.

Performs and provides peer review for the global pharmacovigilance processes: Literature review; Signal detection, Risk Management plans on products developed and manufactured by Apotex. Contributes to drafting and review of aggregate reports and Risk Management plans on 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. Participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities.

Job Responsibilities

  • Manages PSRM team to support Apotex products. Schedules workloads (i.e. aggregate safety reports & projects) and assigns tasks to team to ensure timelines are met.
  • Leads organizational initiatives to drive Global operational excellence in Pharmacovigilance.
  • Ensure the development and maintenance of standard operating procedures, polices, and training to meet global safety reporting requirements and the management of adverse events reports.
  • Represent pharmacovigilance in a cross-functional organizational and alliance partner forums.
  • Responsible for global oversight for regulatory compliance and management of vendor activities.
  • Responsible for planning and prioritizing workload/projects and managing processes to ensure objectives of the department and project timelines are met.
  • Develop solutions and implements action plans for identified issues to mitigate risks, promote compliance, efficiencies, informing and escalating as required.
  • Prepare a monthly report on the activities of PSRM and advises the Drug Safety Committee and senior management when a safety issue is identified.
  • Ensure that pharmacovigilance practices are in place in Apotex to comply with Pharmacovigilance Regulations (i.e. FDA, EMA, MHPDC etc).
  • Stay abreast of changes to pharmacovigilance regulatory environment and trends.
  • Provide technical guidance in the review and evaluation of pharmacovigilance documentation/processes to ensure overall quality and compliance of work.
  • Implement business objectives, R&D initiatives and regulatory strategy.
  • Continually investigates and recommends process improvements as appropriate and acts as a positive change model when business requirements dictate.
  • Works as a member of the Global Pharmacovigilance leadership team to achieve all key performance measures and business objectives.
  • Develop and maintain effective relationships with external vendors, business partners and internal stakeholders in order to ensure business needs are met.
  • Liaise and collaborate with international Apotex affiliates and external business partners involved in safety reporting i.e. Global RA, international PV contacts.
  • Communicate with Health Care Professionals, Consumers, Regulatory Authorities as required when investigating an adverse drug reaction or responding to a safety enquiry.
  • Represent Apotex at key international meetings and networks with Industry colleagues as appropriate.
  • 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).
  • 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.
  • All other relevant duties as assigned.

 

Job Requirements

  • Education
    • Health Care Professional (with medical, dental, pharmacy or nursing qualification).
  • Knowledge, Skills and Abilities
    • Excellent interpersonal, analytical, negotiation and decision-making skills.
    • Excellent verbal & written communication skills in English.
    • Ability to establish and maintain open relationships within the organization and with authorities.
    • Knowledge of Pharmacovigilance database systems, ICSR, MedDRA.
    • Excellent research skills.
    • Knowledge of international Pharmacovigilance regulations (MHPD, TPD, FDA, EMA etc.), ICH guidelines, GMP and GCP documents.
    • Demonstrable knowledge of all local and global PV requirements.
  • Experience
    • Previous industry experience in Pharmacovigilance with 3-5 years.
    • 1-2 years Management experience is preferable.

 

 

 

 

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.