Jayakumar S Punniyaraj
Associate Director, Senior Patient Safety Scientist, Oncology @AstraZeneca
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WORK HISTORY
Associate Director, Senior Patient Safety Scientist, Oncology @AstraZeneca
Luton, GB
Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate. • Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.• Leads structured Benefit Risk (sBR) assessment reports• Lead clinical study report readouts• Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.• Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects.• Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.• Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products. • Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.• Authored and lead the structured Benefit Risk (sBR) assessment report for the developmental products• Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.• Participates in negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.• Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.
EDUCATION
Tamil Nadu Doctor M.G.R. Medical University
Master's degree, Pharmacy
Tamil Nadu Doctor M.G.R. Medical University
Bachelor's degree, Pharmacy
Prince Edward College, Canada
Post Graduate Diploma in Clinical Research, Clinical Research
ABOUT JAYAKUMAR S PUNNIYARAJ
15+ years of experience in pharmacovigilance with a focus on aggregate safety reporting and signal detection.Expert in creating regulatory reports such as Periodic Safety Reports including PSURs/PBRERs, Clinical Overview, safety summary, benefit risk assessment, labeling documents, and other safety-related documents such as Line Listings, Health Authority queries addressal, safety summary, addendum report, etc.Strong knowledge of health authority management, commitment tracking, and query resolution.Proficient in analyzing patient clinical data such as clinical study reports (CSR) and summarizing key findings.Proven ability to identify areas for improvement and recommend strategies to enhance pharmacovigilance practices.Exceptional organizational and time management skills, delivering high-quality results within strict deadlines.Strong understanding of current regulations, guidelines, and industry best practices.Excellent communication and collaboration abilities, working effectively with cross-functional teams and stakeholders.
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