Freelance Consultant for Pharmacovigilance and Regulatory Affairs - Remote

Overview

This is an exciting opportunity for a freelancer / consultant to join our team as Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE.

In Short

• Primary contact person for local regulatory authority / Pharmacovigilance expert as per local requirements
• 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
• Local management / oversight of risk minimization measures
• Review and linguistic input on local Product Information
• Perform local non-indexed literature screening
• Support audits and Inspections
• Handle local QA tasks

Requirements

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience
• Demonstrated experience within pharmaceutical or CRO industry or Regulatory body
• Must have experience within LCPPV / LCPRA roles
• PV training and/or working experience
• Expert knowledge of ICH GVP and local requirements
• Proficiency in English and local language
• Proficiency in MS-Office applications
• Must currently be set up to work as a freelancer / consultant

Benefits

• Competitive salary
• Dynamic team in a fast-growing company
• Multicultural environment
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance
• Friendly working environment with social events