Laura Lamas
Associate Director, Patient Safety Scientist @AstraZeneca
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WORK HISTORY
Associate Director, Patient Safety Scientist @AstraZeneca
Cambridge, GB
Participated in the initial regulatory submission of a product, conducting comprehensive reviews of case narratives, safety data, and key documents (e.g, Modules 2.7.4 and 2.5). Supported the adverse drug reaction (ADR) assessment process, including report writing and presenting findings. Provided cross-functional support on related activities as needed.• Leads and executes pharmacovigilance and risk management strategies for assigned products, including the development of Global Risk Management Plans in close collaboration with safety physician.• Oversees data analysis and signal detection activities, facilitating discussions with cross-functional teams to confirm or dismiss potential safety signals.• Authors high-quality, purpose-driven safety evaluation documents with clear and actionable conclusions, addressing internal and regulatory authority requests.• Partners with safety physicians and clinical teams to develop and maintain Reference Safety Information (RSI) for investigational products; manages timelines and coordinates review meetings to ensure timely delivery.• Leads the drafting and provides strategic input on periodic regulatory safety reports (PBRERs, DSURs, ACOs), ensuring alignment with processes and regulatory timelines.• Provides training and mentorship to junior team members on pharmacovigilance tools and systems.
EDUCATION
ICTQ - Instituto de Pós-Graduação para Farmacêuticos
Post-graduation, Pharmacovigilance pre and post market
Institute of Hygiene and Tropical Medicine
Post-graduation, Tropical Health
IFRJ - Instituto Federal do Rio de Janeiro
Technologist, Biotechnology
Universidade Federal Fluminense
Bachelor's degree, Industrial Pharmacy
SKILLS
ABOUT LAURA LAMAS
Dedicated and results-driven Industrial Pharmacist with over 15 years of specialised experience in pharmacovigilance across industry-leading pharmaceutical companies. Extensive expertise in Individual Case Safety Report (ICSR) management, signal detection and evaluation, Risk Management Plan (RMP) development, and the preparation of key regulatory documents, including DSURs and PBRERs. Proven track record in regulatory authority interactions, safety strategy development, and oversight of Safety Data Exchange Agreements (SDEAs).Currently leading pharmacovigilance and risk management activities at AstraZeneca, with a focus on signal detection, safety documentation, and regulatory submissions. Prior experience includes key roles at GlaxoSmithKline, Kendle International, Genzyme, and Fiocruz, demonstrating a strong and consistent commitment to patient safety and regulatory excellence.Fluent in Portuguese (native), English (fluent), and Spanish (basic). Holds a degree in Industrial Pharmacy from the Federal Fluminense University (2010) and postgraduate qualifications in Pharmacovigilance (2015) and Tropical Health (2018) from the Institute of Hygiene and Tropical Medicine, Lisbon.
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