QLS are recruiting for a PV Specialist to join a Global Biopharmaceutical company based in Lucerne on a contract basis for one year.
Responsibilities:
- Execution of local pharmacovigilance processes and activities in collaboration with internal functional areas and external parties as assigned.
- Day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with pharmacovigilance procedures and country regulations.
- Reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy
- Supporting local pharmacovigilance audits and inspections including readiness activities and supports audits of business partners/vendors including the development of CAPAs in response to findings/observations as assigned.
- Participating in compliance activities and coordinates the preparation of necessary corrective actions locally for late reports.
- Supports training of local company staff, distributors, vendors, and business partners as instructed by their manager.
Qualifications:
- Education in Health, life science, or medical science degree or equivalent by education/experience.
- Experience in the pharmaceutical or biotechnology industry.
- General knowledge of AE (Adverse Events) reporting requirements and relevant PV regulations is preferred
- Must be fluent in English and German (written and spoken). French or Italian skills is an advantage.
- Strong communications, organizational, and time management skills.
- Ability to work in partnership with others (internally and externally) to accomplish quality goals.
- Ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations.
Home office: Willingness to attend the office 2-3 days a week. Onsite presence would be more frequent during the onboarding
Apply:
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote job reference 00055782 in all correspondence.
