Padithem Peggy Hazel

Safety specialist (Apr2022-Present)

• Responsible for processing Serious Adverse Event (SAE) which includes review, safety database entry, tracking, narrative writing, requesting follow-up from site and reporting to client (s) or agencies for assigned projects.
• Responsible for adhering to PPD’s corporate policies, SOPs/WPDs, and awareness of ICH GCP guidelines and other relevant global and local regulations.
• Effectively interface with Project Teams, Client Companies, and Investigators regarding SAE activities.
• Review and understands assigned study specific budgets.
• General understanding of pathophysiology and the disease process, more detailed knowledge of relevant therapy areas as required for processing SAEs.
• Ensure any expedited safety reports are notified to applicable Regulatory Authorities, Ethics Committees and Principal Investigators within regulatory timelines.
• Provide project specific safety training to PPD Clinical on assigned projects
• Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into PPD-owned or client provided adverse event database, review of entered cases for quality, consistency and accuracy, follow up with reporter and/or associated HCP, tracking of reports, and reporting activities.
• Code adverse event terms and write narratives according to client convention.
• Assist with preparation and review of regulatory reports.
• Review literature articles/abstracts and process adverse event reports from literature per program and regulatory requirements.
• Maintain knowledge and understanding of PPD and client-provided SOPs and current local and global regulations.
• Effectively communicate with team members, client contacts and adverse event reporters.

• Activities are performed under the direction and supervision of the lead Safety Specialist or a more senior member of staff. The same verbiage for Safety Specialist (PVG) will be used for this position's CV.
• Responsible for processing adverse event (SAE/AE) triage, data entry into PPD-owned or client provided adverse event database, review of entered cases for quality, consistency and accuracy, follow up with reporter and/or associated HCP, tracking of reports and reporting activities.
• Code adverse event terms and write narratives according to client convention.
• Assist with preparation and review of regulatory reports.
• Review literature articles/abstracts and process adverse event reports from literature per program and regulatory guidelines.
• Maintain knowledge and understanding of PPD and client-provided SOPs and current local and global regulations.
• Effectively communicate with team members, client contacts and adverse event reporters.

• Extensively involved in individual case safety, processing, quality review, following company Standard Operating Procedures, internal business practices and regulatory guidance documents to ensure the compliance with worldwide safety regulations and corporate polices
• Case intake, duplicate check and registration
• Maintain log of source documents and other communications
• Data entry of individual case safety reports into database
• Nmnunyi
• Review and evaluate SAE case information to determine validity of a case, seriousness and expeditedness as per client and internal policies and procedures
• Process all incoming cases in order to meet safety global timelines
• Accountable for performing the appropriate clinical assessments (including assessment causality and labelling based on various regulatory documents such as CDS, IB, BPI and USPI
• Full data entry including medical coding and safety narrative
• Adhere to productivity, timeline compliance and quality of cases
• Accountable for performing the appropriate clinical assessments (including the assessment of seriousness, labelling and causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements
• Code all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (e.g., Med DRA, company product dictionary, WHO-DD)
• Write medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields
• Experienced and skilled in Clinical Pharmacy services like Prescription audit, Drug Identifying, Drug interactions, Patient Counselling, IV admixtures, Adverse drug reaction monitoring and reporting
• Assess patient information and prescriptions to identify drug treatment needs
• Evaluate information and integrate knowledge for the drug treatment problems
• Address therapeutic endpoints and outcomes for individual patients
• Use Drug information retrieval and evaluation skills and acquire information to solve drug related problems
• Counselling and Communicating drug information to health Care professionals and patients.