Manager, Country Safety Lead Switzerland / Liechtenstein

For our offices in Baar (hybrid working model) we are recruiting for a

Manager, Country Safety Lead Switzerland/Liechtenstein

About this role:

The Country Safety Lead (CSL) is the primary Pharmacovigilance (PV) point of contact for the local territories Switzerland and Liechtenstein and will act as a local QPPV (LQPPV). The incumbent will be responsible for the end-to-end operation, management and oversight of local PV tasks in compliance with all applicable local regulations, guidance and global business requirements. Furthermore, she/he is a key strategic partner for the local business and provides valued consultations and collaboration to all affiliate stakeholders and functions to support local objectives.

• Responsible for the fulfillment of LQPPV responsibilities as per local regulation
• 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; contributes as required to the Global Auditing strategy as it relates to the local territory.
• 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;
• Notifies EU QPPV/GSRS of changes in local PV legislation/guidance, changes in PV personnel, and interactions with local Competent Authorities regarding safety issues. Anticipates changes in PV Regulations and plans for changes in local procedure and templates accordingly.
• Fosters an environment of sharing best practices, learnings and innovations with the wider PV and Regulatory affiliate network.

• Responsible for recruitment, onboarding, training, oversight and general end-to-end set-up of PV Operations Vendors and Service Providers; ensures alignment with applicable global oversight strategies for vendors, i.e. safety report reconciliation, vendor quality monitoring, monthly report etc.
• Contributes to and/or leads additional Local, Regional or Global strategic priorities, projects and responsibilities as required.
• Serve as PV contact person in- and externally for local staff, GSRS and health authority
• Ensures business continuity (BC) and identifies BC needs, e.g. resources, deputization etc.

• Responsible for establishing and maintaining optimum and harmonized processes for the receipt, collection and submission (as applicable) of Individual Case Safety Reports (ICSRs) for Company products from any source.
• Managing and triage of Emails received in the country-specific mailbox
• Oversight of ICSR management processes including late cases
• Follow-up activities on safety reports from Biogen Global Safety or Case Processing Partner
• Monitoring of reconciliation activities
• Performing Compliance Activities related to safety reports
• Ensures ICSR submission is performed according to local requirements and tracks local regulatory submission of ICSRs and aggregate safety reports as necessary, in collaboration with medical reviewers.

• Oversight and support of regular local literature monitoring activities

• 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.
• Training of new hires, personnel of Biogen as well as Biogen Service Providers on the PV obligations and reporting requirements of adverse events, pregnancies and product complaints

• 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.
• Inspection-readiness by maintaining appropriate documentation/evidence that demonstrates the efficient and compliant functioning of the local PV structure, including appropriate storage and archiving of safety reports and training records.
• Responsible for local documents, such as Standard Operating Procedures (SOPs), Guidelines, Safety Management Plans/Manuals, Vendor Service Agreements
• 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);
• Assists GSRS with regulatory agency inquiries, CAPA investigation and implementation

• Contributes to the GSRS PV Regulatory Intelligence infrastructure by maintaining a detailed understanding and continuous awareness of the local PV Regulation / Guidance 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.

• Vendor management of PV Service Provider
• Overseeing safety report handling activities performed by service providers

• 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;
• Maintains awareness of all Organized 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)
• Notify the relevant IPV team of local market research programs, studies, patient support programs and any other local program as required.
• Instructs project owner on PV requirements (contract, questionnaire, reporting procedures)
• Reviews project documents and provides PV assessment for upload in local approval system as required.
• Supporting organized data collection activities and the program owners in all relevant aspects of PV
• Managing safety information from local organized data collection systems

• Acts as the local 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.

• Minimum of bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required.
• 3-5 years in drug safety/pharmacovigilance in pharmaceutical industry setting or the equivalent for Manager Level or above.
• In-depth knowledge of Global, Regional and local PV regulations and requirements; expertise in Swiss PV regulation and experience in interaction with Swissmedic required.
• Direct experience in GxP compliant quality systems preferred
• Experience with interacting with third parties (e.g PV operations vendors) required
• 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 German (if not native language). Knowledge of the French language, Italian is a plus.