Senior Manager, Benelux Safety Lead

Job Description

The Benelux Safety Lead is the primary Pharmacovigilance (PV) point of contact for the local territory . fulfilling the role of the Local contact for Pharmacovigilance (LCPPV) in Netherlandsas per National Competent Authority (NCA) guidelines. The Benelux Safety Lead is responsible for the end-to-end setup, operation, management and oversight of local PV tasks in compliance with all applicable local regulations, guidance and global business requirements. The Benelux Safety Lead is a key strategic partner for the local business and provides valued consult and collaboration to all affiliates stakeholders and global functions to support local, regional and global objectives. The Benelux Safety Lead also contributes to the Global and Regional PV strategy as required.

• Accountable for establishing and maintaining a local/regional PV structure and related practices in compliance with local Regulation and in synergy with Biogen’s Global PV system.
• Acts as the local/regional expert in all matters pertaining to PV within the post-marketing space and the aligned territory and provides strategic and operational consult to the local business. Contributes to PV matters in the Clinical space as required in collaboration with other GSRS functions.
• 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.
• Maintains awareness of all Organised Data Collection Programs (ODCPs) (such as Patient Support Programs (PSPs) and Market Research Programs (MRPs), Early 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.
• Authors and maintains PV-related training and ensures regular delivery to all Affiliate staff, PV Operations Vendors and Service Providers including but not limited to training pertaining to AE collection responsibilities.
• Responsible for the identification of outsourcing needs and the recruitment, onboarding, training, oversight and general end-to-end set-up of PV Operations Vendors, Service Providers and other third parties; ensures alignment with applicable global oversight strategies for vendors.
• Leads and collaborates with local Finance and Global Management on budget and resource planning for local PV activities.
• Authors local documents, such as Standard Operating Procedures (SOPs), Guidelines, Safety Management Plans/Manuals, Vendor Service Agreements, and ensures content alignment with GSRS procedures and Local PV requirements; ensures regular updates of these documents as per the established review cycles and as required according to enhancement needs.
• Maintains a constant state of inspection readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the local PV structure. Supports and hosts Post-Marketing inspections to ensure the successful close-out.
• 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); incorporates the use of empirical data (both quantitative and qualitative) to drive continuous improvement of the local PV system.
• Acts as the primary contact and Subject Matter Expert (SME) 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); contributes as required to the Global Auditing strategy as it relates to the local territory.
• Contributes to the GSRS PV Regulatory Intelligence infrastructure by maintaining a detailed understanding and continuous awareness of the local PV Regulation and any updates or changes; actively participates in relevant local trade associations, working groups and creates appropriate connections with local Health Authorities and influential institutions within the PV space.
• Participates in any public consultations on planned changes to PV Regulation in close collaboration with International PV (IPV). Anticipate changes in PV Regulations and plans for changes in local procedure and templates accordingly.
• As required, contributes to projects related to any technical updates to PV practices (e.g. electronic submission of ICSRs to HAs).
• Fosters an environment of sharing best practices, learnings and innovations with the wider PV and Regulatory affiliate network.
• The Benelux Safety Lead is responsible for appropriate communication with local Health Authorities in partnership with other local functions (e.g. Regulatory Affairs and Medical Affairs); collaborates with regulatory colleagues to ensure safety notifications and submission of safety documents are performed in a compliant manner; coordinates with GSRS management to address safety related requests from the local HA.
• Maintains close working connections with all local teams and functions; the primary point of contact to be consulted for all matters that impact PV within the affiliate; a standing member of relevant affiliate governance structures (as needed) 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.
• As is applicable the Benelux Safety Lead is also responsible for the fulfillment of local contact for Pharmacovigilance (LCPPV) Responsibilities as per local regulation; The LCPPV ensures there is comprehensive understanding of these specific responsibilities at the Local, Regional and Global level, in order to enable compliance with regulatory expectations for the role.
• Manages other local safety staff and resources as is applicable.
• Contributes to and/or leads additional Local, Regional or Global strategic priorities, projects and responsibilities as required.
• Completes relevant training on Biogen’s PV system on-time before commencement of local QPPV responsibilities. Maintains a high level of knowledge and understanding on Biogen’s local and global PV systems.

Qualifications

• Minimum of bachelor’s level degree in medicine, pharmacy or life sciences
• Minimum of bachelor’s level degree in medicine, pharmacy or life sciences
• 7+ years in drug safety/pharmacovigilance in pharmaceutical industry setting
• Experience with interacting with third parties (e.g. PV operations vendors) required
• Knowledge of Good PV Practices
• Direct experience in GxP compliant quality systems preferred
• Experience with Adverse Events Intake systems
• Experience in writing procedures, training materials and effectively delivering training to a diverse audience
• Experience (e.g. interviewee, control room, document request) of Audits and Regulatory Inspections preferred.
• Proficiency in English and Dutch native / perfectly fluent / bilingual speaker.

• Must be a resident in the Netherlands

• In-depth knowledge of Global, Regional and local PV regulations and requirements.
• Excellent written and verbal communication skills including.
• Well-developed technical writing skills with the ability to produce clear, concise documentation and communications. Good presentation and analytical skills.
• Excellent Project Management skills.
• Good proficiency with common software such as Microsoft Word, Excel, PowerPoint, Outlook.
• Must work effectively/collaboratively in a fast-paced and matrixed environment.
• Individual has effective managerial skills (as applicable to job role and scope), is a self-starter, ability to adapt - to work independently or as part of a team, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize.
• Strong decision-making skills required.
• Must demonstrate initiative to effectively identify and communicate issues.
• Individual should be able to demonstrate innovative thinking.

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.