Kim Augustine Email and Phone Number
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PHARMACEUTICAL PROFESSIONALPharmacovigilance & Risk Management Leader | Research DevelopmentAggregate Report AuthorLeader in forums, such as Study Management, Safety Review Teams, and Operating Committees. Extensive Global Pharmacovigilance (PV) and Risk Management / drug safety experience. Work independently and collaboratively in a fast-paced, matrixed, team environment with excellent planning, organization, and time management skills. Adapt by supporting and prioritizing multiple projects to changing priorities and deadlines.Consistently demonstrate success and expertise in all aspects of global PV by providing leadership and oversight required at all stages of the product life cycle (clinical development through commercialization) with a strong knowledge of ICH guidelines and global regulations, signal detection activities, quality control review, mentoring, project management activities, and deliverables to Health Authorities and business partners Agreements.Prior to the pharmaceutical industry, worked in Healthcare as a Registered Nurse in various hospital settings and skilled nursing facilities. In the role as Charge and Staff Nurse, responsibilities included oversight and coordination of unit staffing, shift assignments, direct patient care, and education; working with physicians, pharmacists, ancillary staff, and family members.Areas of expertise include: Pharmaceutical Industry, Pharmacovigilance / Drug Safety, Clinical Trials, Medical Writing, Standard Operating Procedures, Regulatory Submissions, Drug Development, New Drug Applications, CRO Oversight, Project Management
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Director, Pharmacovigilance SciencesCrinetics Pharmaceuticals Jan 2023 - PresentSan Diego, California, Us
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Director Pharmacovigilance SciencesRadius Health, Inc. Jun 2021 - Jan 2023Boston, Ma, UsResponsible for management and oversight of:-Company's PV processes in collaboration with key colleagues-Safety surveillance of products during the lifecycle-Implementation of and facilitates MSD and SRT activities/meetings-Preparation and authoring of aggregate reports, topic reports-Creation of templates for DSUR, PADER, PBRER -Oversight and training of CRO vendors-Creation of Argus supplemental outputs with colleague-Presenting SAE and Pregnancy Exposure Reporting at Investigator Meetings-Contributes and comments to relevant Modules for NDA and MAA submissions-Supports PV audits and inspections-Trained new employees within PV -
Associate Director Pharmacovigilance SciencesRadius Health, Inc. Jun 2019 - Jun 2021Boston, Ma, Us
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Associate Director Pharmacovigilance SciencesRadius Health, Inc. Jun 2019 - Jun 2019Boston, Ma, Us
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Associate Director Pharmacovigilance SciencesRadius Pharmaceuticals Jun 2019 - Jun 2019Under the oversight of the VP of Pharmacovigilance and in collaboration with key colleagues, is responsible for management and oversight of the Company’s PV processes, by participating in oversight of all post-marketing and clinical safety PV activities. Ensure compliance with worldwide and local legislation. • Ensure compliance with investigational and post-marketing reporting for assigned product(s)• Prepare and author relevant sections of periodic/annual reports (PADER, DSUR) • Collaborate with PV medical director to prepare and respond to ad hoc regulatory authority queries with signaling topic reports • Facilitate preparation materials and information for Safety Review Team meetings. Ensures that regulatory commitments are efficiently tracked and presented as part of the SRT process. Liaises with SRT chair to facilitate communication and support for decisions resulting from the SRT. • Contributes to training and oversight of pharmacovigilance vendors supporting pharmacovigilance activities for Radius investigational and marketed products. • Maintains a thorough knowledge and understanding of clinical protocol(s) and the scope of work for assigned projects. • Contributes to PV process improvements, standard operating procedures (SOPs), tools, etc., pertaining to pharmacovigilance activities. • Support PV audits and inspections. Participate in audit preparedness activities and serve as subject matter expert during regulatory inspections in collaboration with team members.• Performs other tasks and assignments as needed and specified by management
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Scientist, Medical DirectorRadius Pharmaceuticals Apr 2018 - Jun 2019Under the oversight of the VP of Pharmacovigilance (PV) and in collaboration with key colleagues, is responsible for management and oversight of the Company’s PV processes, by participating in oversight of all post-marketing and clinical safety PV activities. Ensure compliance with worldwide and local legislation.• Ensured compliance with investigational and post-marketing reporting for assigned global products• Prepared periodic/annual reports (PADER, DSUR) • Collaborated with PV medical director to prepare and respond to ad hoc regulatory authority queries with signaling topic reports• Collaborated with PV medical director to ensure appropriate follow up on case safety reports are completed; contributed to safety review meetings; maintained up to date PV processes, SOPs and procedures; ensured development and execution of risk management strategies and author interval risk tracking plans and risk management plans for submission to global health authorities• Developed templates for aggregate reports (PADER, DSUR, PSUR/PBRER), SRT meeting materials including slides, meeting agenda and minutes, project plans, safety evaluation reports, • Developed template for supplemental data listing outputs to assist in authoring of aggregate and safety topic reports or health authority responses • Set up pathway for pharmacovigilance folders SharePoint site
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Medical Safety Scientist, PharmacovigilanceOtsuka Pharmaceutical Companies (U.S.) Sep 2016 - Apr 2018Princeton, Nj, UsAs a contractor for Orbis Clinical at Otsuka Pharmaceuticals responsibilities include but are not limited to:Support activities for products worldwide. Ensure compliance with legislation, and corporate responsibilities, associated with patient safety. Provide oversight of technical and scientific support for safety surveillance, safety review team, and signal detection activities. Author PV safety aggregate reports and support team with responses to regulatory queries.• Adhering to timeline deliverables and industry regulations, authored aggregate reports, health authority responses and NDA submissions for products worldwide.• Participated in development and implementation of new RMPs and updating previous RMP into new EU RMP format.• Supported updates to SOPs, work practice documents, aggregate report templates• Mentored new employees• Demonstrated ability to identify opportunities to improve PV productivity by working with safety data management to create PV data outputs -
Manager Pharmacovigilance & Risk Management (Lead Scientist)Shire Pharmaceuticals 2012 - Aug 2016Tokyo, Jp, JpSupported registration activities of products worldwide. Ensured compliance with legislation, and corporate responsibilities, associated with patient safety. Provided oversight of technical and scientific support for safety surveillance, safety review team, and signal detection activities. PV strategy lead for safety documents and regulatory reports.• Oversaw vendor case processing, confirming accurate use of MedDRA for AE/SAE coding and analyses of narrative details by providing feedback in real time.• Directed preparation and authored responses to health authority safety-related queries and assessment reports on time, adhering to timeline deliverables and industry regulations.• Supported regulatory submission registration and license maintenance of activities for marketed products by providing analyses of all available safety data.• Participated in development and implementation of new RMPs by identifying product risks from various sources (clinical, post-marketing, and literature) and providing risk minimization activities with creation of questionnaires. -
Senior Pharmacovigilance Scientist IShire Pharmaceuticals 2010 - 2012Tokyo, Jp, JpProvided ongoing safety surveillance and contributed to safety profile of products. Verified appropriate follow up completed and accurate case assessments. Ensured compliance with legislation and corporate responsibilities, associated with patient safety, was fulfilled.• Liaised with operations team, confirming safety database algorithm was configured correctly to ensure timely regulatory submissions worldwide.• Proactively developed training materials for internal and external staff on product information and associated risks for newly acquired products that were implemented immediately after the acquisition.
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Senior Pharmacovigilance AssociateShire Pharmaceuticals 2006 - 2010Tokyo, Jp, JpDelivered global departmental oversight and representation on global project teams.• As Subject Matter Expert (SME), demonstrated leadership ability and experience by mentoring and training new colleagues and summer interns on product life cycles, PV processes and Standard Operating Procedures (SOPs). Presented at Investigator, Vendor, and Kick-off Meetings, providing process of AE/SAE reporting and SAE reconciliation.• Contributed to R&D Compliance Team on multi-functional SOPs, identifying areas for process improvement and incorporating recommendations into SOPs.• As a SME, strongly supported and contributed to Global R&D clinical trial development team activities for Phase I-IV trials with consistent timely reviews of clinical essential documents (such as, but not limited to study protocol, Clinical Study Report [CSR], and investigator brochures), providing comments and accurate data, as required.• Compiled and authored accurate and timely aggregate reports (Periodic Safety Update Reports / Periodic Benefit-Risk Evaluation Reports (PSUR / PBRER), Annual Safety Reports (ASR), Development Safety Update Reports (DSUR), Periodic Adverse Drug Experience Reports (PADER), and Safety Topic Reports) and contributed to the development of Risk Management Plans (RMP), liaising with managers, physicians, and cross-functional team members by using standardized templates and providing updates, as necessary meeting global regulatory authority deadlines with 100% compliance for submission of quality safety reports.
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Pharmacovigilance AssociateShire Pharmaceuticals 2004 - 2006Tokyo, Jp, JpCoordinated and orchestrated case intake / receipt, triage, data entry, medical coding, narrative writing, assessment, follow up activities, CIOMS / MedWatch generation, reporting to regulators, and database reconciliation.• Presented at Investigator, Vendor, and Kick-off Meetings as SME for AE/SAE reporting and SAE reconciliation.• Demonstrated ability to identify opportunities to improve the PV reporting processes by communicating recommended changes to SOPs and updates to PV related forms to upper management.• As the SME, coordinated and prepared safety data for monthly and quarterly safety review meetings. Analyzed and presented data in aggregate, ensuring the safety profile of the product did not change.• Obtained postmarketing AE reports, customer complaints, and queries (from consumer calls on all marketed products), ensuring events were accurately captured and coded. Forwarded information to appropriate departments. Participated in development and implementation of product-specific questionnaires to obtain detailed information for AE follow-up for specific AEs of interest.
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PraMds Pharma Services 2000 - 2001King Of Prussia, Pennsylvania, Us -
Pv ScientistThe Covalent Group 2000 - 2001
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RnHahnemann University Hospital 1990 - 2000Philadelphia, Pennsylvania, Us
Kim Augustine Skills
Kim Augustine Education Details
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Allentown Hospital School Of NursingRegistered Nursing/Registered Nurse -
Drexel UniversityMental Health Technology
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Montgomery County Community CollegeGeneral Studies
Frequently Asked Questions about Kim Augustine
What company does Kim Augustine work for?
Kim Augustine works for Crinetics Pharmaceuticals
What is Kim Augustine's role at the current company?
Kim Augustine's current role is Director Pharmacovigilance Sciences at RADIUS PHARMACEUTICALS.
What is Kim Augustine's email address?
Kim Augustine's email address is ki****@****-us.com
What schools did Kim Augustine attend?
Kim Augustine attended Allentown Hospital School Of Nursing, Drexel University, Montgomery County Community College.
What are some of Kim Augustine's interests?
Kim Augustine has interest in Horsham, Additional Related Experience Includes, King Of Prussia, Covalent Group, Jenkintown, Inc, Wayne, Pacharge And Staff And Per Diem Nurse, Pa Charge And Staff And Per Diem Nurse, Philadelphia.
What skills is Kim Augustine known for?
Kim Augustine has skills like Pharmaceutical Industry, Clinical Trials, Pharmacovigilance, Sop, Cro, Clinical Research, Cross Functional Team Leadership, Healthcare, Regulatory Submissions, Drug Development, Regulatory Affairs, Gcp.
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