OverviewApotex Associate, Global Pharmacovigilance (12 month contract) Temporary in Toronto, ON
Branch Toronto ON CA
Associate, Global Pharmacovigilance (12 month contract)
Minimum 3-4 years pharmaceutical industry experience preferably in a clinical, regulatory or Pharmacovigilance role….
Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!
We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds. We’d love to hear how you could contribute to the team!
Global Pharmacovigilance (PV) is an operating department within AXG-Global Pharmacovigilance in Apotex. The PV department is involved in the processing and submission of adverse drug reaction reports and safety data management to support the development and commercialization of Apotex products in the markets in which we do business, in compliance with global PV regulations & relevant ICH guidelines.
Performs global Pharmacovigilance processes of the unit: Medical assessment and quality review of Individual case safety reports (ICSR), including submission to regulatory authorities as needed; Compliance monitoring and tracking; Reconciliation; Literature review, and occasional case processing as needed. 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. When required, participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities relating to Risk Management programs as required.
1. Perform medical review of ICSRs and generate follow-up questions as appropriate
2. Conduct literature assessment for ADRs and medical review of articles
3. Conduct causality assessments for safety cases reports
4. MedDRA coding assessment
5. Perform expectedness and listedness assessment and ICSR reportability
6. Conduct quality review of ICSRs
7. Contribute to submissions of ICSRs when required
8. Assist in the preparation, review and evaluation of signals, aggregate reports and risk management plans
9. Contribute in generating responses to regulatory authority requests on product safety related issues for marketed products or product in development
10. Respond to queries from clients (including internal and external to Apotex Inc.) in a timely manner
11. Perform monthly or quarterly reconciliations of reports as required
12. Assist in the maintenance of unit SODs, Safety Data Exchange agreements with business partners and internal work instructions
13. Maintain departmental document management, including scanning and filing of source documents
14. Contribute to maintenance and compliance oversight of PV processes, external service providers and business partners. May contribute to preparation and training of internal and external customers on adverse events reporting
15. Escalates to Project Leader, calls and requests for Health Care Professional consultation involving safety issues
16. Contribute to process improvement initiatives in consultation with management
17. Maintains user-level knowledge of Oracle ARGUS and Oracle Clinical safety databases and MedDRA terminology
18. Communicates with external customers, pharmacists and physicians to investigate and follow-up on ADR reports during clinical trials, post-marketing and in the literature
19. 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
20. Develops strong relationships with external partners, CROs, international Apotex affiliates and clients (internal and external), demonstrating corporate values in the performance of work and in all interactions with others
21. Interact with Sales and other internal departments when necessary
22. Prepares responses to slightly more complex queries, and requests for safety information from internal customer (RA, QA, NPD project teams etc.)
23. 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
24. Contributes to interpretation of PV regulations and applies sound decisions related to regulatory guidelines and policies
25. Shows initiative to remain current on new PV regulations and international guidelines and seeks guidance from Project Leaders and management to enhance knowledge
26. Performs all work in accordance with all established ICH guidelines, regulatory compliance and safety requirements and maintains current knowledge on all relevant Pharmacovigilance regulations
27. Works as a member of a team to achieve all outcomes.
28. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
29. Performs all work in accordance with all established regulatory and compliance and safety requirements.
30. All other duties as assigned.
* Health Care Professional (e.g. with medical, dental, pharmacy or nursing qualification)
* Minimum 3-4 years pharmaceutical industry experience preferably in a clinical, regulatory or Pharmacovigilance role.
* 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.
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.
Employment Type: Temporary
Location: Toronto, ON, CA
Posted on: 2016-09-21