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 (FUs, translations)
• Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
• Review and linguistic input on local Product Information and Mock-ups
• Perform local non-indexed literature screening and screening of Regulatory Authority website/s for potential Adverse Drug Reactions (ADRs) and safety information
• Support audits and Inspections
• Handle local QA tasks such as suspected falsified products, quality alerts received from HA and other quality-related requirements received from the local market

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 and other educational or professional background as required locally
• Expert knowledge of ICH GVP and most relevant legislation/ local requirements for territories of competency
• Proficiency in English, both written and verbal and in local language
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Must currently be set up to work as a freelancer / consultant

Benefits

• Competitive salary
• Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals
• Friendly working environment with several social events per year