Safety Spec Full-time Job

PPD's mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

As a Safety Specialist you will be responsible for completing daily Pharmacovigilance tasks.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose: Performs day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.

Essential Functions: Performs day-to-day PVG activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites. Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintain medical understanding of applicable therapeutic area and disease states. Reviews cases entered for quality, consistency, and accuracy, including review of peer reports. Prepares and maintains regulatory safety reports. Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less experienced staff

Additional / Specific Job Responsibilities: Conducts assessment and peer review of literature abstracts/articles for adverse events, special situation events, signal-relevant and aggregate safety report-relevant safety information and

analysis of similar events (AOSE) for both developmental and market-authorized products.

Serves as the primary point of contact for low to medium complexity literature projects (e.g. medium complexity projects with 1 to 5 products, projects involving review for ICSRs, signalrelevant, aggregate safety report-relevant safety information and/or AOSE, and projects with

moderate to high volume of citations).

Ensures that assigned literature surveillance tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.

Participates in departmental initiatives.May prepare for and attend audits, inspections and bid defenses. PPD's mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

As a Safety Specialist you will be responsible for completing daily Pharmacovigilance tasks.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose: Performs day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.

Essential Functions: Performs day-to-day PVG activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites. Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintain medical understanding of applicable therapeutic area and disease states. Reviews cases entered for quality, consistency, and accuracy, including review of peer reports. Prepares and maintains regulatory safety reports. Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less experienced staff

Additional / Specific Job Responsibilities: Conducts assessment and peer review of literature abstracts/articles for adverse events, special situation events, signal-relevant and aggregate safety report-relevant safety information and

analysis of similar events (AOSE) for both developmental and market-authorized products.

Serves as the primary point of contact for low to medium complexity literature projects (e.g. medium complexity projects with 1 to 5 products, projects involving review for ICSRs, signalrelevant, aggregate safety report-relevant safety information and/or AOSE, and projects with

moderate to high volume of citations).

Ensures that assigned literature surveillance tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.

Participates in departmental initiatives.May prepare for and attend audits, inspections and bid defenses.

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