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Freelance Consultant for Pharmacovigilance and Regulatory Affairs - Remote

Posted 1 week ago

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

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