Roxana Grecu Email & Phone Number | Medical Doctor with over 10 years experience in clinical research (drug safety/pharmacovigilance and clinical trials). Current roles: - deputy QPPV: establishing and maintaining the MAH’s PV system, generation and maintenance of Pharmacovigilance System Master File, ongoing safety monitoring of the MAH’s products, signal detection and benefit-risk evaluation, generation and maintenence of PSPs and PV relevant documents, oversight of the QMS, regulatory documents production and review (PSUR/PBRER), review and update of SmPC, Company Core Data Sheet, benefit-risk profile assessment, communication with European Medicines Agency and Competent Authorities, participation in audits and inspections. - Project Manager: resource and workload management, assurance of regulatory compliance, assurance of safety data quality, budget and invoice management, client interation on updates, progress and issue on a regular basis, generation and maintenance of Pharmacovigilance System Master File, oversight of pharmacovigilance system, KPIs, CAPA management, PV training for company employees. - Drug Safety Physician: assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events and of Adverse Drug Reactions, provide assessment of safety issues arising in clinical trials or in the post-marketing setting, literature screening and surveillance, signal management, aggregate safety data analysis (DSURs, PSURs, regulatory communication).

Roxana Grecu

Medical Doctor with over 10 years experience in clinical research (drug safety/pharmacovigilance and...
Frankfurt Am Main, Hesse, Germany

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Roxana Grecu’s Location Frankfurt Am Main, Hesse, Germany

Roxana Grecu’s Current Industry Icon Clinical Research

Roxana Grecu’s Prior Industry Ppdabcro

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Drug Safety Physician

2013-10-01 00:00:00 - Present

Clinical Research Associate

2007-05-01 00:00:00 - 2009-12-01 00:00:00

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Roxana Grecu is a Medical Doctor with over 10 years experience in clinical research (drug safety/pharmacovigilance and clinical trials). Current roles: - deputy QPPV: establishing and maintaining the MAH’s PV system, generation and maintenance of Pharmacovigilance System Master File, ongoing safety monitoring of the MAH’s products, signal detection and benefit-risk evaluation, generation and maintenence of PSPs and PV relevant documents, oversight of the QMS, regulatory documents production and review (PSUR/PBRER), review and update of SmPC, Company Core Data Sheet, benefit-risk profile assessment, communication with European Medicines Agency and Competent Authorities, participation in audits and inspections. - Project Manager: resource and workload management, assurance of regulatory compliance, assurance of safety data quality, budget and invoice management, client interation on updates, progress and issue on a regular basis, generation and maintenance of Pharmacovigilance System Master File, oversight of pharmacovigilance system, KPIs, CAPA management, PV training for company employees. - Drug Safety Physician: assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events and of Adverse Drug Reactions, provide assessment of safety issues arising in clinical trials or in the post-marketing setting, literature screening and surveillance, signal management, aggregate safety data analysis (DSURs, PSURs, regulatory communication).