Job Advert Title: Pharmacovigilance Affiliate Lead
Location: Switzerland, Wallisellen
Division: Pharmacovigilance
Department: Pharmacovigilance Department
Employment Class: Permanent
Astellas is announcing a Pharmacovigilance Affiliate Lead opportunity, based in Switzerland.
Purpose & Scope:
Essential Job Responsibilities:
Strategy Development and Execution
Contributes to development and implementation of 1-3 year Global, Regional Affiliate Support and Local specific objectives and plans as part of the overall PV strategy and plans. Participates in the successful execution and implementation of Global Affiliate Support and Business Partners’ vision, mission, objectives and plans.
Provides PV leadership and strategic direction to the local PV dept in the country/affiliate. If applicable, line management of the local PV dept staff employees.
The Pharmacovigilance Affiliate Lead is accountable for:
General department
Actively investigate and implement ways in which the PV department can contribute to the compliance, efficiency and overall effectiveness of the affiliate.
Implement locally new initiatives, management tools or processes in cooperation with PV-Affiliate Support Function. Ensure that all affiliate PV staff have access to the necessary tools and systems.
Ensure collaborative and appropriate liaison between PV-Affiliate Support Function, the affiliate MT and the competent authorities. Operate and be recognized as (Be) the key contact for the competent authorities for PV.
Ensure that processes, procedures and PV files are well documented in an up-to-date and
complete archive i.e. ‘audit/inspection ready’ status.
If applicable:
Ensure full PV support by the local business partners and coordinate the required contribution from the local business partners to the PV system and requirements.
Provide input and support to PV HQ with management of department budget.
Management of Product Safety Information
Lead and if applicable provide effective management of product safety information. To ensure that safety information (Adverse Events) received from all sources by the affiliate are collected, translatedand forwarded to designated Regional Global PV Headquarter, in compliance with required timelines (reporting timelines), quality guidelines and standards. If applicable: Timely ICRS submissions to the Competent Authority
Ensure that the PV Case Tracking System, PV Register is used to accurately capture Product Safety Information, and to be responsible for ensuring that the PV Register is maintained in real-time.
Be responsible for monitoring caseload trends to ensure sufficient resources are allocated to manage fluctuating PV caseload. Be responsible for monitoring interactions with vendors that are used to conduct PV services
PV Quality and Compliance
Accountable for management and coordination of all PV activities in alignment with regulatory requirements and internal Astellas procedures to ensure full compliance with Regulatory requirements.
Is responsible for the implementation of relevant updates to PV regulations (including maintenance reporting rules matrix), within the required timeline. Communicate any changes to PV Affiliate Support Function, EU-QPPV, the GPV Regional HQ Office and/or other local business functions, as applicable.
Accountable for ensuring compliance with local and regional PV regulations and Astellas policies/procedures and take corrective and/or preventive actions, as appropriate and required.
Involvement in due diligence of potential new product acquisitions/local country licensing agreements if applicable
Maintenance of PV System and Oversight Responsibilities
Accountable to provide input for the PSMF regarding the affiliate communication to GPV regional Head Quarters To ensure Astellas affiliate is GPvP inspection-ready: project management related to regulatory authority, business partner or internal inspections. Act as the main point of contact, and as such, coordinate regulatory authority.
inspections in collaboration with QA and GPV: both announced and unannounced - as and when required.
Responsible and accountable for PV self-assessments, PV audits/inspections at the affiliate and assist in developing CAPAs (with qualitative/quantative measures and timelines) in response to findings/observations
Is responsible for ensuring that qualification of PV vendors is conducted and periodic audits are requested.
Manage outsourced partners to ensure PV activities are conducted according to the relevant procedures
Provide support to establish contracts with Vendors and License Partners: subject to language ability.
Responsible for the Quality Management System (QMS), including QA and QC activities
Accountable and responsible for the development and maintenance of locally applicable PV Quality documents.
Ensure filing, storage and archiving of PV documentation in accordance with PV regulations and with Astellas policies and procedures
Request to have access to, and be aware of, the affiliate business continuity plan (for example system failure and other disasters) in relation to PV activities. Accountable for ensuring a local mechanism is in place for 24/7 availability to enable appropriate handling of potential urgent safety issues by the affiliate.
Ensure oversight and monitoring of all local studies and projects, including digital media and Astellas sponsored websites that impacts PV.
Support in the development of safety monitoring and reporting plans for clinical trials that impact the affiliate. Ensure local post-marketing programs (e.g. Post Authorization Studies [PAS], Post Authorization Programs [PAP] or market research, post marketing surveillance [PMS]) protocols are reviewed for compliance with PV requirements, as applicable.
Ensure that changes of Affiliate PV and/or Business Partners are communicated to the PV Affiliate Support Function
Participate in local activities concerning Risk Management Plans and Risk Minimization Measures
Act as the safety expert for the update of SmPCs/PILs
Relationship management
Serve as the point of contact for the PV- HQ functions, PV Affiliate Support Function, the affiliate MT and M&D functions.
EMEA only: Liaise with the EU-QPPV (periodic and ad-hoc) through PV Affiliate Support Function, to enable the EU-QPPV to maintain the required PV system oversight
Act as liaison between Legal and the GPV regional HQ office for legal complaints / litigation upon request and as needed
Liaise with PV Affiliate Support function and/or PV Business partner Management function for the development of PV Agreements (PVAs) impacting the country/region. Participation in Due Diligence activities for local country licensing agreements
Accountable for ensuring that communications from local competent authorities are forwarded to the Regional PV office - and work with the GPV Regional HQ Office and Regulatory Affairs - to ensure appropriate response are presented to local competent authorities, where applicable.
Training
Ensure implementation, annual delivery, and documentation of PV Product Safety Awareness training to Affiliate (e.g. Medical Information, Sales Rep, receptionists). Also, where applicable, to third party personnel providing PV-related services, and to other staff within the territory.
Monitor PV Product Safety Awareness training completion and compliance of the affiliate
Maintenance of local PV Training Role Matrix
Quantitative Dimensions:
Organizational Context:
Reports to (Sub Regional) Lead PV Affiliate Support Function. Peers include Affiliate Lead RA/MA/QA and Affiliate Leads (DSOs) of other countries.
If applicable, line management of the local PV dept.staff employees (up to 3) and resourcing responsibility
Collaborates with PV regional affiliate support members to support a global consistency in approach across regions.
Collaborates with other M&D affiliate support members and local functions such as the Medical Directors, Regulatory Affairs Managers and General Managers
Qualifications:
Required
Preferred