Apotex Inc. Pharmacovigilance Associate (Signal Detection/PSUR) in Toronto, Ontario
Apobiologix is a member of the Apotex Group of Companies, the largest Canadian-owned, pharmaceutical company with sales in 115 countries across the world. Founded in 1974 by Dr. Barry Sherman, Apotex is one of the world's leading suppliers of high-quality, affordable pharmaceutical products. The success of Apotex is founded on its culture of quality and its commitment to manufacturing safe and effective medicines, meeting strict regulatory standards and making healthcare accessible to millions of people worldwide.
In 2007, the Apotex group formed an R&D division dedicated to the development of biosimilar products. Biosimilars are new versions for exisiting biopharmaceuticals made in cellular biologic systems and are approved on the basis that they are highly similar to the reference product in terms of quality, safety and efficacy. Biosimilars are not generics because biologic drugs cannot be copied exactly.
The success of our initial R&D efforts with biosimilars has enabled Apotex to create a completely new line of business known as Apobiologix. This R & D group has expanded to include both a medical affairs team and commercial operations, which is structured to allow us to develop our own products coupled with the capabilities to commercialize those products and ones developed by others.
In August of 2014, our first biosimilar, Grastofil (filgrastim) was launched in the EU for all approved uses of its innovator biologic. Grastofil has now also been launched in Canada and we await approval from the US FDA for both Grastofil & Lapelga (pre-filgrastim).
With continued support from Apotex, and success of this first wave of supportive care biosimilar products we will be able to expand our existing pipeline of therapeutic protein biosimilars.
Our long term vision is to create sustainable health care that doesn't sacrifice quality and that brings value to the healthcare system, physicians' practice and the patients we serve.
Performs and provides peer review for the global pharmacovigilance processes: Clinical trial SAE reporting; Spontaneous ADR reporting: literature review; Signal detection, Risk Management plans on products developed and manufactured by Apotex. Interacts on a peer level with internal customers (Apotex affiliates), and external customers (health professionals, consumers) during investigation of all case reports. Prepares/ reviews periodic safety update reports (PSURs/PBRERs) in compliance with drug safety regulations and ICH Guidelines. Participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities.
Processes, evaluates and conducts peer review of all suspected adverse drug reaction reports on Apotex products occurring in clinical trials, during postmarketing and in the literature, ensuring timely entry into the global safety database Oracle-ARGUS.
Conducts literature reviews and provides assessment and analysis of published literature.
Prepares and conducts peer review of periodic safety update reports (PSURs 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. Informs management of trends and prepares the PLCM Unplanned Change Event Summary Report for the Drug Safety Committee.
Assists in the preparation of Risk Management plans when required.
Provides input on the selection and evaluation of external service providers involved in the safety data exchange process.
Develops and maintains SOPs, Safety Data Exchange Agreements with business partners, and training documents and tracks compliance of internal and external global partners involved in drug safety reporting.
Acts as delegate for Project leader, GPV
May provide input and feedback to departmental process improvement strategy discussions
Communicates with external customers, pharmacists and physicians to investigate and follow-up on all ADR reports during clinical trials, post-marketing and in the literature.
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.
Maintains user-level knowledge of Oracle ARGUS and MedDRA terminology.
Interacts with other internal departments when necessary.
Prepares responses to slightly more complex queries, and requests for safety information from internal customer (RA, QA, NPD project teams etc.).
Resolves GPV unit and risk management program issues with internal customers and team members and participates in resolution of issues with external service providers and business partners. * 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 Project Leaders 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.
Works as a member of a team to achieve all outcomes.
Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
Performs all work in accordance with all established regulatory and compliance and safety requirements.
All other duties as assigned.
B.Sc,M.Sc.,in Pharmacy, Nursing or related Health Science discipline
3-5 years pharmaceutical experience in a PV role.
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
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.
System ID: 2016-4867
Job Type: Full Time
Job Industry (Choose up to 3 industries): Pharmaceutical
Career Level: Experienced