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Shire Senior Pharmacovigilance Specialist in Toronto, Canada
Under the direction of the Region Head of Global Drug Safety (GDS) and Head, Drug Safety Canada, the Safety Lead Canada is assigned to fulfill regional or country pharmacovigilance obligations relating to medicinal products and biologics for which Shire holds the Marketing Authorisation (further referred to as "Shire products") in Canada.
Under the direction of the Head, Drug Safety Canada, the Safety Lead is responsible for:
Implementation of Shire's pharmacovigilance system on a country level
Maintaining an efficient vigilance system in compliance with Health Canada as well as global Pharmacovigilance (PV) regulations and guidelines
Answer to safety questions from Health Authorities or Customers.
Country/Region pharmacovigilance responsibility and authority
Fulfill country/region pharmacovigilance responsibilities as assigned.
Ensure that country/region role and responsibilities are adequately reflected in individual job description and periodically reviewed.
Undertake timely and relevant training for the role including relevant Shire GDS policies and procedures as assigned by GDS Training
Ensure contact availability in line with country requirements and business continuity including delegation of applicable duties and responsibilities when planning time out of the office.
Monitor regional/country Pharmacovigilance related regulations maintaining knowledge of them with particular reference to any deviations from standard ICH / EU definitions, requirements or any new changes with impact on the PV-system and communicate accordingly
Implement Shire's pharmacovigilance system at the country level in accordance with country legislation and exercise oversight of the pharmacovigilance system in the country
Support GDS in the development of the PSMF annexes.
Support training of local personnel on the policy on employee responsibilities for supporting the pharmacovigilance system
Serve as country/regional primary contact point for pharmacovigilance system related questions, dealing with queries made concerning general pharmacovigilance issues.
Local Vendor Oversight
Represent GDS as lead contact, and collaborate with GDS Alliance Management, PV Agreements colleagues, to advise country stakeholders on the inclusion of Pharmacovigilance language in Safety Data Exchange Agreements / Service Agreements with third parties.
Support and document training of local vendors as appropriate.
Collection of safety information, follow up for additional information and reporting to health authorities
Support collection, documentation, and processing of adverse events. Ensure consistent and effective follow up according to global procedures.
Ensure translation of all adverse events information (initial and follow-up) into English from local language if required.
Submit individual case safety reports (ICSRs) to applicable Health Authorities and business partners as required.
Awareness of product lists and requirements for periodic reporting for country products.
Screen Health Canada’s Vigilance Adverse Reaction Online Database website for adverse events/safety information related to Baxalta/Shire products.
Liaise with Quality colleagues as appropriate for country quality complaints.
Periodically review, and document such review, and any actions taken, to assure that the local medical or scientific journals in the country are covered by the global database search.
Assist GDS Safety Surveillance by collating relevant country information in support of their roles (i.e. data for aggregate report preparation, signal detection).
Liaise with Central Drug Safety to ensure that pharmacovigilance processes are adequately addressed and reflected in protocols/supporting documentation for country initiatives where safety data may be directly or indirectly collected. Collaborate with Clinical Development and Medical Affairs as appropriate.
Increase company internal awareness of patient safety and Global Drug Safety’s role in ensuring it.
Enhances the integration of drug safety in the local business
Shifts the focus of the Regional and Local Drug Safety role to allow more local interaction, connection, collaboration and awareness of local business activities and needs.
Represent GDS at the regional/country level through membership in collaborative activities such as Quality Management meeting, franchise leadership team meetings, the R&D Council, involvement in new product launches and market preparation activities (as applicable).
Represent GDS on review of country prescribing information, Patient Support Programs (PSPs), Market Research Projects (MRPs), as appropriate.
Quality Management System
Assist with audit/inspection preparation. Lead any regional/country authority PV inspections if legally required.
Under the direction of the GDS Process Standards and Training, take responsibility for the development of country quality management and the preparation of Country controlled procedural documents or work instructions, as mandated in the country, ensuring integration with GDS procedures.
As part of the QMS provide and document drug safety training including but not limited to Training on Safety Information reporting, Product RMP training and PSP/ MRP registration process. Train the appropriate target groups within the country/regional organization as well as external partners about ongoing/ or under review safety issues as necessary.
Education and Experience Requirements
Pharmacy qualification or other healthcare related degree (fulfilling country/regional mandated requirements for a ‘Country Responsible Person for GDS’) is required.
Generally has at least 3 years of drug safety experience in a pharmaceutical company.
Post-graduate qualification is desirable.
French, oral and written is an asset
Key skills, Abilities and Comeptencies
Excellent oral and written communication skills, interpersonal skills and cultural awareness.
Ability to liaise effectively with the different functions Quality, Regulatory Affairs, Medical Affairs, Manufacturing, Sales & Marketing; and external audiences (e.g., Health Canada, Health Care Professionals and patients).
Good computer skills. (Word, Excel, PowerPoint skills)
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.