As a manager in Pharmacovigilance Manager, Canada you will contribute and manage oversight for pharmacovigilance activities for the affiliate. You will act as the local expert in all matters pertaining to PV within the post-marketing space and the aligned territory and maintains close working connections with all local teams and functions; the primary point of contact to be consulted for all strategic and operational matters that impact PV within the affiliate; a standing member of relevant affiliate governance structures to be kept up to date on local plans and projects that may have an impact on PV; provide strategic and operational recommendations to affiliate teams and projects to facilitate compliance with PV requirements.

Primary Responsibilities

• Accountable for establishing and maintaining a local PV structure and related practices in compliance with local Regulation and in synergy with Biogen’s Global PV system.
• Maintains awareness of all Organised Data Collection Programs (ODCPs) (such as Patient Support Programs (PSPs) and Market Research Programs (MRPs)), Extended Access Programs (EAPs), Compassionate Use (CU),  Registries, Digital and Social Media Activities that are relevant to the local territory; ensures appropriate PV Processes are in place (e.g. Adverse Event Collection); ensures adherence with the Global PV Governance structure and procedures.
• Responsible for establishing optimum and harmonized processes for the receipt, collection and submission (as applicable) of Individual Case Safety Reports (ICSRs) for Company products from any source. Ensures procedures related to Literature Screening and ICSR Follow-up are in place.
• Where applicable ensures Health Authority submission compliance of Aggregate Reports; maintains an up-to-date knowledge of local regulatory requirements for Aggregate Reporting and effectively ensures timely communication of all related Regulatory intelligence to the International Pharmacovigilance (IPV) team regional management and other GSRS functions as concerned and collaborates with GSRS functions as required (e.g. negotiation of submission timelines with local Health Authority).
• Authors and maintains PV-related training and ensures compliance and regular delivery to all Affiliate staff, PV operations vendors and service providers including but not limited to training pertaining to AE collection responsibilities.
• Prepare and participate in internal and external audits, and in regulatory inspections. Maintains a constant state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the local PV structure.
• Acts as Subject Matter Expert (SME) in collaboration with manager for local Audits and as required for local HA Inspections (including the interviewee role and collating responses to document requests); plays a lead role in the facilitation and coordination of local audits and inspections in collaboration with the applicable Quality teams; ensures there is timely and appropriate communication throughout the life-cycle of the Audit or Inspection to key Local and Global stakeholders including International PV (IPV regional management); contributes as required to the Global Auditing strategy as it relates to the local territory.
• Contributes to the global strategy for PV oversight and compliance management; implements effective measures to monitor compliance and quality of key local PV procedures and operations (including but not limited to ICSR collection and Health Authority (HA) submissions, as applicable) in the post-marketing space in collaboration with International PV (IPV regional management); incorporates the use of empirical data (both quantitative and qualitative) to drive continuous improvement of the local PV system.
• Participates in any public consultations on planned changes to PV Regulation in close collaboration with International PV (IPV regional management). Anticipate changes in PV Regulations, when possible and plans for changes in local procedure and templates accordingly.
• Maintains a detailed understanding and continuous awareness of the local PV Regulatory intelligence (e.g. regulations, directives, Good Pharmacovigilance Guidelines (GvPs)), and any updates or changes.

• •5-6 (10) years working experience in the Regulatory and Pharmacovigilance field of the (bio)pharmaceutical industry
• University degree in natural sciences (e.g. Pharmacy, Biology, Chemistry) or adequate training in conjunction with at least 10 years working experience in a similar position in the Regulatory field of the (bio)pharmaceutical industry.
• Versed in MS-Office, web applications, Regulatory relevant databases (e.g. intelligence tools such as Cortellis), as well as in electronic Document Management Systems and electronic review system
• Language: Fluency in English

As a manager in Pharmacovigilance Manager, Canada you will contribute and manage oversight for pharmacovigilance activities for the affiliate. You will act as the local expert in all matters pertaining to PV within the post-marketing space and the aligned territory and maintains close working connections with all local teams and functions