The Sirius management team
Owner and Head of QA and Regulatory Affairs
Elise Hellesø Rinvar is M.Sc. pharm from Copenhagen University, with over 20 years of
industry experience within EU Regulatory Affairs, GMP, GDP and Pharmacovigilance for
both human and veterinary medicines, working for both the largest international pharma
companies and small family-owned companies. Have been responsible for construction of EU
GMP compliant injectable and oral solid dosage form facilities in India, have managed
Research and Development laboratory in India, have worked as Quality and Bioequivalence
assessor in the Danish Medicines Agency, and has owned consultancy companies in UK and
Norway, and as now in Denmark and Malta.
Head of Safety and Efficacy and Medical Doctor within Pharmacovigilance
Dr. Shailendra Vikram Singh is MD (Pharmacology) from Regional Institute of Medical Sciences (RIMS), Imphal, Manipur, India and MBBS from Dr. Vaishampayan Memorial Government Medical College, Solapur, Maharashtra, India. He has almost 5 years of experience in Pharmacovigilance as Physician for Individual Case Safety Report (ICSR), Medical Devices, Combination Products, Global Para Pharmaceutical Products (Non-Drug Cases), Suspected Unexpected Serious Adverse Reactions (SUSAR) and Signal Management for international companies. He has 2 years of clinical experience and worked as Emergency Medical Officer in State Government.
Head of Pharmacovigilance and EU QPPV
Madalina has studied pharmacy at the university of Medicines and Pharmacy, Carol Davila,
in Bucharest, and has almost 20 years of industry experience within pharmacovigilance. She
has worked as QPPV and deputy QPPV in large US based and EU based pharma companies,
and has also been Pharmacist Manager, Acquisition Manager and warehouse manager.