Lina Montoya
Drug Safety and Pharmacovigilance Lead, Deputy Eu Qppv @Telix Pharmaceuticals Limited
Signup · Get unlimited contacts
WORK HISTORY
Drug Safety and Pharmacovigilance Lead, Deputy Eu Qppv @Telix Pharmaceuticals Limited
Acting as Deputy EU QPPV for Telix PharmaceuticalsSupport the Qualified Person for Pharmacovigilance (QPPV) in ensuring EU compliance for pharmacovigilance activitiesOversee safety reporting, risk management, and regulatory submissions for EU operationsCollaborate with cross-functional teams to maintain up-to-date safety data and documentationAssist with audits, inspections, and continuous improvement of pharmacovigilance processesContribute to the preparation of safety updates, periodic reports, and compliance communications with EU authorities
EDUCATION
Université de Lyon
Msc 2 Public health, Pharmacology and Modelisation in clinical trials
Universidad de Antioquia
Doctor of Pharmacy - PharmD, Facultad de Química Farmacéutica
Université Claude Bernard Lyon 1
Master Health Engineering and Medicines
ABOUT LINA MONTOYA
With over 14 years of experience in the pharmaceutical industry, I am a passionate and dedicated drug safety professional who strives to ensure the highest standards of quality and compliance in pharmacovigilance. I have a strong background in pharmacology, clinical trials, and public health, with a PharmD degree from Universidad de Antioquía and a MSc degree from Université de Lyon. As the Safety Manager Europe/Principal Safety Specialist at Precision Medicine Group, I lead, support, and coordinate drug safety reporting and related activities for various projects and clients, providing strategic input, subject matter expertise, and staff training and mentoring. I value collaboration, innovation, and continuous improvement, and I aim to leverage my diverse skills and perspectives to contribute to the company\'s mission and vision.In my current role at Precision Medicine Group, I oversee the planning, setup, maintenance, and closure of drug safety services, including costing, budgeting, resourcing, workflow and process design and analysis. I also liaise with internal and external stakeholders, such as business operations, account management, clients, third party vendors, health authorities, and business partners, to ensure effective and efficient communication and delivery of services. I use my data analysis, laboratory, and SOP skills to monitor and ensure the quality and compliance of case processing, QC, and regulatory submissions in Argus database. I also represent Safety when required for internal and external audits, inspections, and meetings. I take pride in my work and I seek to provide excellent customer service and satisfaction.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.