FSP Pharmacovigilance Coordinator – Night Shift

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

📋 Description

• Facilitate the timely assessment of protocol inquiries, both serious and non-serious adverse events, diagnostics, and Data Safety Monitoring Board data.

• Monitor necessary data and create reports for clients, project teams, and external vendors.

• Represent the DSMB/EAC Coordination Team at both global and domestic committee meetings through teleconferences and in-person formats.

• Organize meeting logistics and assist in facilitation alongside clients, board members, third-party vendors, and project teams.

• Draft Confidentiality Disclosure Agreements, Letters of Intent, and Member Agreements.

• Review contracts for accuracy and coordinate both internal and external approvals.

• Assemble adjudication dossiers and create/submit follow-ups to investigative sites.

• Coordinate and lead project meetings; prepare minutes and distribute blinded/unblinded materials via client portals.

• Oversee project-specific training and manage program file setup, maintenance, and archival to ensure pharmacovigilance programs are audit-ready.

• Identify and redact subject identifiers, retrain sites, and escalate recurring issues to Data Privacy.

• Conduct data entry into databases, tracking systems, and budget management systems.

• Reconcile systems to detect issues that may adversely impact project timelines.

• Supervise expenses and manage translations within budgetary constraints.

• Handle incoming hotline calls and coordinate departmental functions.

• Support activities performed by the local office that cannot be executed elsewhere.

• Provide training to junior staff.

⛳️ Requirements

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

• Technical roles may necessitate a certificate.

• Prior experience that provides the knowledge, skills, and abilities to perform the job (equivalent to at least 2 years).

• Strong problem-solving capabilities.

• Ability to work independently with minimal supervision.

• Capacity to build strong relationships.

• Proficiency in analyzing project-specific data/systems for accuracy and efficiency.

• Effective liaison abilities and respectful, diplomatic communication with clients, management, project team members, and internal staff.

• Strong oral, written communication, and interpersonal skills.

• Excellent computer proficiency, including MS Office (Word, Excel, PowerPoint, Access).

• Ability to prioritize and manage multiple tasks simultaneously under strict deadlines.

• Strong attention to detail and accuracy.

• Flexibility to adjust workload priorities based on changing project timelines.

• Working knowledge of relevant FDA Regulations, ICH Good Clinical Practices, organizational/client SOPs, and WPDs for non-clinical and clinical project implementation, execution, and closure.

• Willingness to work night shifts or long, varied hours when necessary.

• Occasional travel to site locations may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Standard Monday–Friday work schedule.

• Opportunities for training and development, including training for junior staff.