FSP Pharmacovigilance Coordinator – Night Shift

🔥 12 hours ago

🇵🇭 Philippines – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Night Shift

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Coordinate timely review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data • Track required data and generate reports for clients, project teams and external vendors • Represent the DSMB/EAC Coordination Team at global and domestic committee meetings via teleconference and face-to-face formats • Coordinate meeting logistics and assist with facilitation alongside clients, board members, third-party vendors and project teams • Prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements • Review contractual documents for accuracy and coordinate internal and external approvals • Compile adjudication dossiers and create/submit follow-up to investigative sites • Coordinate and facilitate project meetings; draft minutes and distribute blinded/unblinded materials through client portals • Manage project-specific training and program file setup, maintenance and archival to keep pharmacovigilance programs audit-ready • Identify and redact subject identifiers, retrain sites and escalate recurring issues to Data Privacy • Perform data entry into databases, tracking systems and budget management systems • Reconcile systems to identify issues that may negatively affect project timelines • Oversee expenses and manage translations within budget parameters • Answer incoming hotline calls and coordinate department functions • Support activities performed by the local office that cannot be performed elsewhere • Provide training to junior staff

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Technical positions may require a certificate • Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) • Strong problem-solving skills • Ability to work independently with minimal supervision • Ability to build strong relationships • Ability to analyze project-specific data/systems for accuracy and efficiency • Effective liaison and respectful, diplomatic communication with clients, management, project team members and internal staff • Effective oral, written communication and interpersonal skills • Excellent computer skills, including MS Office (Word, Excel, PowerPoint, Access) • Ability to prioritize and perform multiple tasks simultaneously under strict deadlines • Strong attention to detail and accuracy • Flexibility to reprioritize workload according to changing project timelines • Working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, organizational/client SOPs and WPDs for non-clinical and clinical project implementation, execution and closeout • Ability to work night shift / long varied hours when required • Potential drives to site locations and rare travel may be required

🏖️ Benefits

• Fully remote work arrangement • Full-time employment • Standard Monday–Friday work schedule • Training and development opportunities, including training to junior staff

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