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.
• Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products

• 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.

• 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.
• 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.
• 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.

• 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.

• 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.
• 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.
• 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.

• 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.

Master'S Degree, Health Information Systems

Bachelor’S Of Science In Nursing, Nursing