Soa Rakotozafy
Associate Director, Pharmacovigilance & Patient Safety (Global) @Tolmar
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WORK HISTORY
Associate Director, Pharmacovigilance & Patient Safety (Global) @Tolmar
CO, US
Oversight and Direction for Tolmar global and local PV activities with Business Partners and outside service vendors;Serve as a point of contact for Global pharmacovigilance (PV);Work on the Pharmacovigilance requirements including the EU-RMP, and creating and maintaining the SOPs/WI, development, and maintenance global and local RMPs as required;Work collaboratively with other PV experts within Tolmar and Business Partners and provide input for team decision making;Oversee and supervise PV global outsourcing activities through identification, selection, negotiation, management, and maintenance of Good Pharmacovigilance Practices and required PV activities in assigned projects or therapeutic areas;Evaluate current signal detection activities and recommend advances for continuous improvement;Collaborate with the ongoing aggregate review and analysis of commercial products’ safety data by reviewing adverse events and signal detection observations. Critically evaluate signal detection data, and review summary metrics and compliance reports and distribute reports within Tolmar per internal SOPs; Lead the responses to regulatory agencies for PV in relevant territories related to Tolmar product(s);Support Tolmar by providing or coordinating medical opinions related to ICSR inquiries, etc. with Tolmar products;Lead and support internal and external audit and inspections, and maintain audit and inspection readiness. Drive preparedness for regulatory authority inspection and internal audits for aggregate reporting processes;
EDUCATION
Université de Rouen
Associate's degree
Rhodes University
Bachelor's degree
For drug consulting
Pharmacovigilance
SKILLS
ABOUT SOA RAKOTOZAFY
Bilingual (English and French) pharmacist with a passion for patient safety and more than 15 years of experience in pharmacovigilance at both affiliate and global level in pharmaceutical industry. Expertise in adverse event management, including medical review and raising queries for comprehensive medical review; periodic reports (for investigational and postmarketing products) writing/oversight for worldwide health authorities; medical writing support for RMP update; product safety profile monitoring contribution; signal detection and global/local safety surveillance activities; leading risk management working groups in the identification, evaluation, and prioritization of PV risks; authoring and delivery of consistent and compliant safety information for regulatory submission and other development program documents; external vendor training and oversight. Therapeutic areas: Diabetes and Cardiovascular diseases, Central nervous system, Internal medicine, Oncology, Multiple sclerosis, Devices/Combination products, Rare diseases, Generic and OTC medicines, Immunotherapy and Vaccines (including COVID-19).
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