Full-Time LCPPV/LCPRA - English & German

• Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance.
• Prompt and effective communication with local regulatory authorities.
• Provision of local regulatory intelligence screening and expert advice.
• Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations).
• Local management / oversight of risk minimization measures.
• Preparation and collection of documentation for submissions to the regulatory authorities.
• Review and linguistic input on local Product Information and Mock-ups.
• Development and implementation of local pharmacovigilance system.
• Perform local non-indexed literature screening.
• Maintain accurate records and documentation at local level.
• Support audits and Inspections.
• Handle local QA tasks.

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience.
• Minimum 3 years within pharmaceutical or CRO industry or regulatory authority.
• Minimum 2 years within LCPPV role, or relevant pharmacovigilance experience.
• Pharmacovigilance training and/or working experience.
• Prior experience in Regulatory Affairs is preferred.
• Expert knowledge of ICH GVP and relevant local legislation.
• Proficiency in English and German, both written and verbal.
• Strong skills in Microsoft Office applications.

What is the last date for applying to the job?

Which countries are accepted for this remote job?