Drug Safety Associate

This is a fully remote position, open to applicants in Philippines.

📋 Description

• Oversee the timely assessment of protocol inquiries, manage abnormal lab alerts and diagnostics, track essential data, and produce reports for clients, project teams, and external vendors.

• Identify and redact subject identifiers in accordance with local regulations; retrain sites and escalate recurring issues to PPD Data Privacy.

• Administer project-specific training alongside the project lead/manager, including the application of training within the learning management system.

• Conduct data entry into tracking systems and perform system reconciliations to pinpoint issues that may impact project timelines.

• Organize and facilitate project/client meetings, draft meeting minutes, upload them to client portals, and distribute materials to both internal and external teams.

• Oversee the setup, maintenance, and archiving of program files within PPD's electronic filing system.

• Collaborate with internal functional groups to implement projects and ensure that contractual obligations and timelines are adhered to.

• Respond to incoming hotline calls and relay information from the Incoming Information Center to designated teams.

• Assist with activities conducted by the local office that cannot be executed remotely.

⛳️ Requirements

• High school diploma or equivalent, along with relevant formal academic or vocational qualifications.

• Technical roles may necessitate a certification.

• Prior experience that provides the necessary knowledge, skills, and abilities to fulfill the role, typically ranging from 0 to 1 year.

• A combination of appropriate education, training, and/or directly related experience may be deemed sufficient for equivalency.

• Strong oral and written communication skills, along with effective interpersonal abilities.

• Proficient computer skills, particularly with MS Office (Word, Excel, PowerPoint, Access).

• Capability to identify and prioritize tasks while managing multiple responsibilities under tight deadlines.

• Keen attention to detail and a commitment to accuracy.

• Ability to work autonomously or within a team with moderate supervision.

• Capacity to maintain a positive and professional demeanor during challenging situations.

• Flexibility to adjust workload priorities to accommodate changing project timelines.

• Familiarity with applicable FDA Regulations, ICH Good Clinical Practices, and organizational/client Standard Operating Procedures (SOPs) and Work Practice Documents (WPDs) for project implementation, execution, and closure.

🏝️ Benefits

• Fully remote work.

• Collaboration and development are integral to the everyday experience.

• Reasonable accommodations available for individuals with disabilities.

• Commitment to equal opportunity employment.