Project Leader, Sovo-gqc-sovo S

6 months ago

North York, Canada Apotex Inc. 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**:
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 of global pharmacovigilance processes and activities including but not limited to: ICSR review and processing; regulatory reporting; case document management; literature reviews; and Compliance. Oversees the Apotex managed pharmacovigilance activities of business partners

Interacts with internal (Global Business Services, Regulatory Affairs, Apotex Affiliates) and external customers (vendors and business partners) in relation to Pharmacovigilance process compliance.

**Responsibilities**:

- Oversees and Performs applicable activities to support the Apotex Quality Management System, including oversight review of predetermined activities undertaken by vendors and Global Business Support function.
- Leads and manages the day to day PV activities associated with business partners, including negotiation and management of PV Agreements and the compliance to such..
- Leads the review and oversight of ICSR submissions undertaken by the Global Business Support Team as required to ensure compliance targets are not missed.
- Oversees case processing activities and responds to queries as raised by the Vendor.
- Provides back up to Manager, Vendor Oversight and Safety Operations in their absence.
- Contributes to process improvement initiatives in consultation with management, updates SOPs accordingly.
- 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 and business partners when necessary.
- Takes initiative to remain current on new PV regulations and international guidelines and seeks guidance from management to enhance knowledge. Interprets PV regulations and applies sound decisions related to regulatory guidelines and policies.
- Performs all work in accordance with all established ICH guidelines, data privacy, regulatory compliance and safety requirements. 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
- B.Sc., M.Sc., in Pharmacy, Nursing or related Health Science discipline
- Knowledge, Skills and Abilities
- Excellent analytical and problem-solving skills
- Excellent oral/written communication in English
- Adanced knowledge of MeDRA, Oracle ARGUS or other Global Safety Database
- 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
- 5+ years pharmaceutical experience in a PV role
- Bilingual in English & French 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.

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