Associate, Safety Operations

5 months ago

North York, Canada Apotex Full time

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

Job Summary

One Year Contract

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 oversight quality check activities of global pharmacovigilance processes including but not limited to: ICSR review and processing; regulatory reporting; case document management; literature reviews. Occasionally helps with reviews of Individual case safety reports (ICSR) and submissions to regulatory authorities, as needed. Interacts with internal (Global Business Services, Regulatory Affairs, Apotex Affiliates) and external customers (vendors) in relation to Pharmacovigilance process compliance.

Job Responsibilities
Performs secondary review of determined percentage of completed ICSRs to ensure they have been processed, reviewed and submitted in accordance with Global Pharmacovigilance procedures and regulatory requirements.
Performs applicable activities to support the Apotex Quality Management System, including oversight review of predetermined activities undertaken by vendors and Global Business Support function.
Assists in the review and oversight of ICSR submissions undertaken by the Global Business Support Team as required to ensure compliance targets are not missed.
Responds to case processing queries as raised by the Vendor.
Manages and repsonds to ATI requests received from Legal
Provides back up to Manager, Vendor Oversight and Safety Operations in their absence.
Contributes to process improvement initiatives in consultation with management.
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.
Develops strong relationships with external partners, and international Apotex affiliates and demonstrates corporate values in the performance of work and in all interactions with others.
Interact with other internal/external departments and third party vendors 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 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.
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
Ideally Health Care Professional (e.g. with medical, dental, pharmacy or nursing qualification) or have demonstrable experience within pharmacovigilance with a high level of medical knowledge.
Knowledge, Skills and Abilities
Excellent detail orientated skills
Excellent technical & research skills
Excellent oral/written communication in English; bilingual preferred
**Advanced knowledge of Microsoft office**: Excel, PowerPoint, Word
Working Knowledge of safety databases, MedDRA coding convention
Excellent organizational & interpersonal skills; experience in working in a dynamic team environment
Knowledge of GMP, GCP, relevant PV regulations and ICH guidelines on safety data management in clinical trials and post-approval
Experience
Minimum 4-5 years pharmaceutical industry experience preferably in a Pharmacovigilance role.

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.

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