[Hiring] PV Coordinator @CS201607383 PPD Pharmaceutical Development Philippines Corp.

May 30, 2025

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description At Thermo Fisher Scientific Inc., we are on a mission to enable our customers to make the world healthier, cleaner, and safer. We are looking for a dedicated Drug Safety Admin Associate II to join our world-class team. This role offers an outstanding opportunity to contribute to groundbreaking work in a collaborative and inclusive environment. Essential Functions Coordinate the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics, and Data Safety Monitoring Board (DSMB) data. Track all necessary data and generate flawless reports for clients, project teams, and external vendors. Represent the DSMB/EAC Coordination Team at global and domestic committee meetings, coordinating all logistical aspects and assisting with facilitation. Collaborate with internal and external parties to implement projects, prepare Confidentiality Disclosure Agreements, Letters of Intent, and Member Agreements, ensuring all contractual documents are accurate and approved. Compile adjudication dossiers and build/submit follow-ups to investigative sites. Coordinate and facilitate project meetings, draft meeting minutes, post blinded and unblinded minutes/materials to client portals, and distribute to project teams. Manage project-specific training and the setup, maintenance, and archival of program files, ensuring audit readiness. Identify and redact subject identifiers per local requirements, train sites, and bring up reoccurrences to Data Privacy. Perform data entry into internal/external databases, tracking systems, and budget management systems; perform system reconciliations to identify potential issues. Coordinate expenses and manage translations, ensuring budget parameters are met. Answer hotline calls, coordinate department functions, and perform other duties as assigned. Support activities specific to the local office that cannot be performed elsewhere. Provide training to junior staff. Job Complexity Work on assignments that are semi-routine but may require deviation from accepted practice. Job Knowledge Apply acquired job skills and company policies and procedures to complete tasks. Supervision Received Follow established procedures on routine work, requiring instructions only for new assignments. Business Relationships Typically interact with individuals within the department and occasionally with external contacts, involving the exchange of information requiring some explanation. Requirements Strong problem-solving skills Ability to work independently with minimal supervision Demonstrated ability to foster positive relationships Effective in analyzing project-specific data/systems for accuracy and efficiency Skilled in acting as a liaison and communicating diplomatically with clients, management, and team members Self-motivated with a positive attitude and excellent communication skills Proficient in MS Office (Word, Excel, PowerPoint, Access) Ability to prioritize tasks and meet strict deadlines Strong attention to detail and meticulous work orientation Professional demeanor in challenging circumstances Flexibility to adapt to changing project timelines Knowledge of FDA Regulations, ICH Good Clinical Practices, and SOPs for non-clinical/clinical project aspects Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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