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Freelance Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - Pretoria

Ergomed plc

This is an exciting opportuniy for a freelancer to join our team as Local Contact Person for Pharmacovigilance and Regulatory Affairs Opportunities are open to any geographical location and with flexible working hours. By working with us, you will have the opportunity to work in an international team and strength 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 Apply Now
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