R Jay K

Clinical Research - 10 Years of Experience - Near 18901


Clinical Research


Doylestown, PA

Education Level:

Medical Degree

Will Relocate:



Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards, safety committees and other crucial external partners * Excellent understanding of safety operations, Individual Case Safety Reporting and Periodic /aggregate reports functioning, including working with external vendors * Experience with special studies and initiatives (including Interventional Studies, PASS (Post Authorization Safety Studies), Patient Support Programs, and Non-Interventional Studies * Good knowledge of CFR 21 Part 11 and MDR Regulation "*CFRPart=803" (21 CFR 803) * Executive and leadership functioning experience of different dimensions. Multidisciplinary pharmaceutical expertise. Extensive pharmaceutical experience across clinical development, clinical operations, pharmacovigilance including signal detection, risk management. Experience in academic research functionalities (including cooperative group based clinical research) PROFESSIONAL EXERPIENCE Currently: From 06/2013 Director, Global Safety Officer (GSO) (immunology, mAb, anti-invectives, vaccines) CRU (now CSU) Drug Safety medical lead and main interface Physician Chair, Safety Management Team (SMT) /Medical Safety Assessment - Development & Marketed products TA: Oncology/Hematology, Immunology Biosimilar Responsibilities: * Provided medical expertise to the GMS TA and medical oversight of non-physician Global Medical safety GMS staff including (direct management of 4 PV physicians): * on a daily basis defining the safety question or issue requiring medical safety assessment and initiating the needed action * Developing the strategy for the safety review and analysis * Interpreting results and determining the medical importance of question or issue * Reviewing and approving (i.e., signatory) medical assessment reports, e.g. ad hoc safety reports, response to Health Authorities, study reports (safety aspect) * Prepared/reviewed documentation, answering safety-related questions when requested by specific local Regulatory Authorities, in collaboration with regulatory affairs and other applicable units ensuring compliance * Led safety management for clinical development programs assigned * Provided end-to-end (Phase 1 through product life cycle) safety support and surveillance * Chaired a multidisciplinary Safety Management Teams (SMT) for assigned products whose responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)), as well as other activities related to managing the safety profile of assigned products. Also chaired an Alliance Safety Working Group (SOWG) with external development/Marketing Pharma partners * Managed underreporting staff and matrix budget, staffing and operations * Participates on TA Clinical Development Teams (CDTs) and Clinical, (CTs), CMC, Quality Control, Epidemiology, and Labeling Teams decision making sessions * Presents medical safety and risk management evaluations as necessary to the CSO, the GMS Senior Leadership Team, and the Global Safety Council (GSC) * Led activities for product quality complaints (PQC) investigations, risk assessment and health hazard evaluation reports * Led signal detection activities (manual and on empirica signal) and signaling via SITs * Led aggregate report activities for assigned products: Authors relevant sections of PSUR and conclusions of product safety profile for PSUR. Authors and signs off on ad hoc safety and other safety aggregate reports * Oversaw Individual Case Safety Reports (done by Pharmacovigilant Physicians -PVP ) and led weekly case review meeting of selected single cases (Clinical & Spontaneous reports) assuring compliance of reporting for all reported AEs/SAEs * Functioned as dotted line lead for medical reviewers/PVPs (on case reviews), safety scientists (aggregate reports) * Established, monitored and implemented processes according to established charters for business alliance partners / licensees *Instituted and signed contracts with external partners, KOLs, and hired external authoritative consultants. Led safety aspect of labeling updates * Owned and chaired the Risk Management Plan development and updating for assigned products * Was responsible for safety sections of clinical trials /documents: Protocol, IB, Informed Consent, Study Reports (Clinical Overview, CSR, SCS, SCE and others) * Participated in HA interactions regarding safety and risk management, both written and verbal * Provided input and review to key regulatory and clinical documents as appropriate, to ensure these key safety documents are of high medical/scientific quality and meeting compliance requirements. These might include: * Clinical Trial Protocols * Safety Sections of Investigator's Brochure (IB) and IB addenda * Clinical Study Reports (CSR) * Annual Safety Reports (ASR/SBR) * Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings * Periodic Safety Update Report (PSUR/PBRER, DSUR) * Core Data Sheets (CDS) * Informed Consent Form Risk Template Worked across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety. for inquiries/requests from HAs Led CRU Drug Safety review as member of the Rimonabant "War team' Management of TA Medical Safety staff Reviewed finalized and approved for distribution Pharmacovigilance/safety information for assigned products (drug & device) Led a group of medical reviewers ( Case Medical Evaluators) Reviewing individual safety report (ICSR) for expectedness causal association and providing company's comments Assured timely and accurate processing and reporting of all adverse events (AE) reports for all entrusted products from clinical trials post-marketing studies (PMS) Spontaneous Reports (SR) registries commercial programs that are processed in the s-a Safety Database





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