Senior Drug Safety Specialist – Day Shift

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

📋 Description

• Operates autonomously to carry out daily pharmacovigilance (PV) activities. May also engage in on-call responsibilities for specific projects to ensure round-the-clock coverage for case intake from investigative sites.

• Functions in a leadership role, contributing to the creation of program and departmental procedural documents. May prepare for and participate in audits, while mentoring junior staff.

• Reviews regulatory and pharmacovigilance literature and resources to stay informed about current regulations, practices, procedures, and proposals. Maintains a medical understanding of relevant therapeutic areas and disease states.

• Evaluates cases submitted for quality, consistency, and accuracy, which includes reviewing peer reports.

• Accountable for the routine implementation and coordination of projects (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), which includes delivering presentations at client and investigator meetings, and assessing metrics and budget considerations.

⛳️ Requirements

• Bachelor's degree or an equivalent relevant formal academic/vocational qualification.

• A minimum of 4 years of experience in PV case processing (Clinical Trial or Post-marketed). Familiarity with the Argus database is essential.

• Comprehensive understanding of pathophysiology and disease processes.

• Strong knowledge of pertinent therapeutic areas necessary for adverse event processing.

• Exceptional critical thinking and problem-solving abilities, with a capacity to evaluate situations and escalate issues appropriately.

• Proficient in the administration of complex clinical studies, including budget management and forecasting.

• Outstanding oral and written communication skills, including the ability to paraphrase effectively.

• Proficient in English with the capability to translate information into the local language when necessary.

• Computer literate with the ability to navigate multiple databases.

• Skilled in Microsoft Office applications (including Outlook, Word, and Excel).

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development