Global Pharmacovigilance Requirements

PV Associate Director; Yingxia has 12-years' working experience in China Pharmacovigilance at Sanofi and Boehringer Ingelheim from 2011, and 4-years' working experience in pre-clinical research at Stealth Peptides from 2007. Also is a member of China Quality Assurance Forum (CQAF) PV Working Group

PV Physician Yanjie has 5-years' working experience in China Pharmacovigilance at IQVIA, Celgene and Boehringer Ingelheim, and 4-years' working experience in nutritional products adviser and medical information handling at Sanofi, Roche Diagnostics and Eli Lilly.

Deputy General Director "Technical Affairs" 15 years’ experience in different fields comprising RA and IPR in the pharmaceutical area. As a member of SIPSMENA team, Ala’a has been subjected to various other areas in the pharmaceutical industry such as agent selection, legal requirements, market access and others.
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Pharmaceutical Consultant and Drug Safety Expert; Jennifer (Jen) True is a pharmacist with over 25 years of experience in the pharmaceutical industry. Her career has been focused in the areas of Drug Safety/Pharmacovigilance (PV), Project Management, Quality, and Training. During her time at Abbott and Lilly, she performed all types of PV activities (e.g., case processing, signal management, aggregate reporting). She also managed global safety organizations of various sizes, covering a very broad spectrum of PV activities. Jen spent several years in pharmaceutical consulting with companies such as Ernst & Young/Cap Gemini, Seibel/Oracle, and Galt. She has successfully managed multi-million-dollar projects focused on technology implementation, process redesign, and acquisitions. Over her career, Jen has provided quality support to PV, Regulatory, Clinical (phase I-III), Clinical Labs, Companion Diagnostics, and Sales & Marketing departments. She has redesigned quality systems and managed multiple audits and regulatory inspections (FDA, EMA, MHRA). Jen has worked on numerous human resource initiatives, including improvement of organizational design, development of job descriptions, and creation of competency models. She has actively led training programs, including forming of training strategy and development of training and training matrices. She is known for her practical approaches, communication skills, ability to manage both strategy and implementation details, and follow-through.

Founder and CEO

Dr Petra Lerner-Hiller has more than 20 years of experience in leading positions in the pharmaceutical industry in the areas of quality assurance (GVP, GCP) and pharmacovigilance, including the functions of German "Stufenplanbeauftragte" and EU QPPV. In her current role, Dr Lerner-Hiller is Deputy QPPV and also PV System Strategy and QPPV Relations Lead, responsible for the strategic oversight of the pharmacovigilance system including its quality management system and communication with local QPPVs word-wide.

Dr Rehak is an expert on registration and PV in Russia and EAEU. From 2011 to 2014, she has been working as Regulatory Director at Sanofi and Medical Director at Zentiva, based in Moscow, and prior to that, from 2006 to 2009, as Head Regulatory and QA for Novartis, based in Kiev, Ukraine. Until 2006, she held several positions in product development and clinical research at Sandoz/HEXAL, Germany. She offers consultancy services in registration of medicinal products and PV in Russian and EAEU.
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Pharmacovigilance group leader for FIFARMA and Patient Safety Lead for Roche S.A.

Regulatory Affairs Director