Kim Augustine Email & Phone Number

San Diego, California, US

Boston, MA, US

Responsible 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.

Boston, MA, US

Boston, MA, US

• Under 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.
• 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.
• Contributes to training and oversight of pharmacovigilance vendors supporting pharmacovigilance activities for Radius investigational and marketed products.

• Under 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.
• 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.
• Developed templates for aggregate reports (PADER, DSUR, PSUR/PBRER), SRT meeting materials including slides, meeting agenda and minutes, project plans, safety evaluation reports,

Princeton, NJ, US

• As 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.
• 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

Tokyo, JP, JP

• Supported registration activities of products worldwide. Ensured compliance with legislation, and corporate responsibilities, associated with patient safety. Provided oversight of technical and scientific support for.
• 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.

Tokyo, JP, JP

• Provided 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.
• 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.

Tokyo, JP, JP

• Delivered 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)..
• 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.
• 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.

Tokyo, JP, JP

• Coordinated and orchestrated case intake / receipt, triage, data entry, medical coding, narrative writing, assessment, follow up activities, CIOMS / MedWatch generation, reporting to regulators, and database.
• 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..

King Of Prussia, Pennsylvania, US

Philadelphia, Pennsylvania, US

Diploma Program, Registered Nursing/Registered Nurse

Bachelor’S Degree, Mental Health Technology

Associate’S Degree, General Studies