Ollie A. Email & Phone Number

• Participate in ongoing safety data review and analysis for products in designated therapeutic areas.• Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with Safety Medical Directors• Responsible for project managing and authoring of safety documents including PSUR, PBRER, PADER, RMP, CSRs, and ad hoc requests in collaboration safety physicians.• Authors high quality aggregate safety reports to meet regulatory and internal deadlines; ensures all safety regulatory documents are processed and submitted according to regulatory requirements• Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.• Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products• Assists GDS Medical Directors to oversee risk minimization activities including tracking of activities as needed• Assists in the evaluation of risk minimization activity• Assist with responses to regulatory inquiries related to risk management plans under the guidance of GDS Medical Directors.• Supports activities related to new drug applications and other regulatory filings• Contribute to on-going process enhancement for safety analytics and reporting, such as developing standard procedures and templates.

• Conduct thorough and continuous pharmacovigilance surveillance to identify, assess, and report adverse drug reactions and safety signals in compliance with regulatory requirements.• Collaborate with cross-functional teams, including medical, regulatory, and clinical, to collect, review, and analyze safety data from various sources such as clinical trials, literature, and post-marketing surveillance.• Evaluate and contribute to the development and maintenance of safety databases, ensuring accurate and up-to-date documentation of adverse events.• Assist in the preparation of periodic safety reports, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and other regulatory submissions.• Contribute to the development and implementation of risk management plans for clinical trials and post-marketing activities.• Perform signal detection activities, including the identification and evaluation of potential safety signals, and collaborate on risk-benefit assessments.• Respond to inquiries and requests for safety-related information from healthcare professionals, regulatory authorities, and internal stakeholders.• Participate in the development and review of standard operating procedures (SOPs) and guidelines to ensure compliance with pharmacovigilance regulations and industry best practices.

• Collaborate with safety leads and cross-functional teams to actively support safety surveillance and risk management for designated clinical studies, ensuring the benefit-risk profile is maintained throughout the product lifecycle.• Evaluate safety data from various sources, identifying potential safety signals, and use a global electronic tracking tool to monitor and analyze safety signals. Contribute to safety action recommendations, risk minimization plans, and present assessments in relevant forums such as the Safety Management Team (SMT).• Work with the Clinical Safety Scientist Lead and Product Safety Lead (PSL) to create materials, including presentations and safety analyses, for SMT and product-level safety meetings.• Develop essential product safety requirements to be included in Clinical Study Protocols (CSPs) and Informed Consent Forms (ICFs).• Collaborate with the Clinical Safety Scientist Product Lead and PSL to formulate the Safety Management Plan for the designated product.• Review Statistical Analysis Plans (SAPs), statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documents.• Author safety sections of various documents, including Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), and Risk Management Plan(s) (RMPs).• Contribute to regulatory authority requests or communications related to the assigned clinical studies

• Conduct comprehensive signal detection activities to identify potential safety concerns and evaluate their clinical significance.• Lead safety contribution in the development of the protocol, IB, ICF and aggregate reports (DSUR & PBRER)• Perform case processing tasks such as data entry, coding, narrative writing, and quality control of individual case safety reports (ICSRs).• Prepare and submit expedited and periodic safety reports to regulatory authorities within specified timelines.• Collaborate with cross-functional teams to assess risks associated with pharmaceutical products and develop risk management plans.• Ensure accurate and up-to-date data entry and maintenance of the safety database, generating and analyzing safety reports to identify trends and patterns.• Conduct systematic literature searches to identify relevant safety information, summarize findings, and evaluate their impact on product safety.• Stay updated with global pharmacovigilance regulations, guidelines, and industry best practices to ensure compliance during data collection, processing, and reporting.• Collaborate with internal stakeholders to facilitate effective risk management strategies and provide insights in signal review meetings.

• Monitored investigator sites with a risk-based monitoring approach: applied root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.• Ensured data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assessed investigational product through physical inventory, record review and document observations in reports and letters in a timely manner using approved business writing standards. • Escalated observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. • Conducted monitoring tasks in accordance with the approved monitoring plan. • Participated in investigator meetings and payment process as necessary.• Identified potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiated clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations.• Ensured that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.• Provided trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.• Ensured study systems are updated per agreed study conventions. • Facilitated effective communication between investigative sites, the client company and the project team through written, oral and/or electronic contacts.• Responded to company, client and applicable regulatory requirements/audits/inspections.• Assisted in preparation of project publications/tools and sharing ideas/suggestions with team members. • Contributed to other project work and initiatives for process improvement, as required.

• Actively recruit eligible participants for oncology studies and conduct thorough screening assessments.• Coordinate day-to-day activities, ensuring adherence to protocol, timelines, and regulatory standards.• Perform clinical procedures, manage data collection, and assist with query resolution.• Provide comprehensive patient care, addressing inquiries and managing adverse events.• Collaborate with interdisciplinary study teams and relevant departments for smooth operations.• Ensure strict regulatory compliance, maintaining IRB submissions and GCP standards.• Contribute to study quality assurance through preparation for monitoring visits and internal audits.

Master'S Degree, Health Information Systems

Bachelor’S Of Science In Nursing, Nursing