Freelance Consultant - Local Contact Person for Pharmacovigilance and Regulatory Affairs
November 27, 2024
Description
• 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
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