For our client, one of the leading Healthcare & Life Sciences companies based in the area of Zug, Swisslinx is seeking a highly motivated individual to take on a challenging role as a Country Safety Lead (Pharmacovigilance). This is a contract position for at least 7 months.
The Country Safety Head will serve as the primary Pharmacovigilance (PV) point of contact for the local territory, 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.
- Accountable for establishing and maintaining a local PV structure and related practices in compliance with local Regulation and in synergy with our client's Global PV system
- Responsible for the identification of outsourcing needs and the recruitment, onboarding, training, oversight and general end-to-end set-up of PV Operations Vendors and Service Providers
- Authoring local documents, such as Standard Operating Procedures (SOPs), Guidelines, Safety Management Plans/Manuals, Vendor Service Agreements
- Responsible for establishing optimum and harmonized processes for the receipt, collection and submission of Individual Case Safety Reports (ICSRs) for Company products from any source
- Maintaining awareness of all Organized Data Collection Programs (ODCPs)
- Acting 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
- Notifying EU QPPV/GSRS of changes in local PV legislation/guidance, changes in PV personnel, and interactions with local Competent Authorities regarding safety issues
- Acting as the primary contact and Subject Matter Expert (SME) for local Audits and as required for local HA Inspections
- Authoring and maintaining PV-related training and ensures regular delivery to all Affiliate staff, PV Operations Vendors and Service Providers
The ideal candidate:
- Minimum of bachelor’s level degree in nursing, pharmacy or other health care related profession or life sciences
- 3-5 years in drug safety/pharmacovigilance in pharmaceutical industry setting or the equivalent for Manager Level
- Knowledge of Good PV Practices
- In-depth knowledge of Global, Regional and local PV regulations and requirements
- 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
- Proficiency in English and German
Candidates must have a valid Swiss or European permit or work rights to be considered for this position.
We look forward to hearing from you!