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