Opera CRO
Opera CRO is a clinical research organization based in Romania, previously known as Opera CRO. The company has rebranded to Tigermed and is focused on providing comprehensive clinical research services to support the pharmaceutical and biotechnology industries.
Clinical Research • Clinical Trials • medical devices • early phsase research • proof of concept
Freelance Consultant - Local Contact Person for Pharmacovigilance and Regulatory Affairs
March 4
Opera CRO
Opera CRO is a clinical research organization based in Romania, previously known as Opera CRO. The company has rebranded to Tigermed and is focused on providing comprehensive clinical research services to support the pharmaceutical and biotechnology industries.
Clinical Research • Clinical Trials • medical devices • early phsase research • proof of concept
📋 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. • 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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