(Ol333) Freelance / Consultant 0.5 Fte Local Contact Person For Pharmacovigilance And Regulator[...]

Job Description
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.
By working with us, you will have the opportunity to work in an international team and strengthen your expertise within the broad and diverse PV and Regulatory Affairs area.
Main Responsibilities 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

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