Job Detail

Job Summary(Primary function)

The Senior Specialist, PhV Affiliate Governance and QPPV Office provides the support necessary to ensure the governance and oversight of the local pharmacovigilance (PhV) functions, PSMF maintenance and EU QPPV office activities are fulfilled.

The Senior Specialist, PhV Affiliate Governance and QPPV Office, has an important role in the maintenance and development of the pharmacovigilance Affiliate SharePoint site, and in the maintenance, development and/or improvement of tracking tools.

The Senior Specialist, PhV Affiliate Governance and QPPV Office, supports the activities of the local PhV function in Switzerland.

Essential Functions of the Job (Key responsibilities)

• Maintains the PhV Affiliate Governance and Oversight trackers with up-to-date information


• Maintains the LPPV contact list


• Tracks and monitors activities performed by the local PhV functions


• Performs governance activities as instructed by PhV Affiliate Governance management


• Maintains and develops the PhV Affiliate SharePoint site as instructed by PhV Affiliate Governance management


• Maintains accesses to the PhV Affiliate SharePoint site and maintains the related Working Instruction


• Maintains, develops and improves tracking tools (e.g., Excel)


• Escalates identified deviations to the PhV Affiliate Governance management


• Participates to audits and inspections, assists with the preparation of CAPAs


• Monitors the preparation of CAPA plans and tracks CAPAs of local PhV functions/local Affiliate PhV audits


• Participates to the development and improvement of processes (SOPs, WIs)


• Assist the PSMF coordinator to ensure maintenance of the PSMF and Annexes


• Files QPPV documentation, supports QPPV notifications to EMA/local Health Authorities


• Supports the preparation and scheduling of meetings


• Monitors the PhV Affiliate Governance mailbox


• Supports xEVMPD data maintenance


• Supports Pharmacovigilance activities at the Swiss Affiliate including e.g. management of adverse events (e.g. receipt, tracking, follow-up, reconciliation, and submission), support to the development of local procedures, local literature search, participation in local audit and inspection, and Swiss legislations


• Maintains files and systems as appropriate.


• Completes additional tasks as assigned by management

Qualifications(Minimal acceptable level of education, work experience, and competency)

• Bachelor’s degree in a science or healthcare related discipline, or equivalent.


• Minimum of 4 years pharmacovigilance experience, preferred 2 years with PhV Affiliate Governance and QPPV Office.


• Experience as LPPV, deputy LPPV, or other local PhV role preferred.


• ICSR processing-submission, tracking activities and filing of documents, reconciliation activities, experience with Argus database preferred.


• Understanding of global pharmacovigilance regulations (e.g, GVP, ICH Guidelines) and pharmacovigilance system


• xEVMPD certified preferred.


• Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).


• Proficiency in using and developing SharePoint sites


• Ability to work effectively within a team environment.


• Strong tracking, coordination and project planning skills.


• Solid organizational, time management, and problem-solving skills.


• Excellent verbal and written communication skills.


• Fluency in written and verbal English.


• Fluency in written and verbal German preferred. 


• Travel (domestic and global) 10%.