Senior Drug Safety Specialist – Night Shift

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

📋 Description

• Execute and potentially oversee daily Pharmacovigilance operations in a highly regulated and deadline-oriented environment.

• Gather, monitor, assess, evaluate, research, and track safety information.

• Work collaboratively with project team members, clients, investigators, adverse-event reporters, and third-party vendors.

• Participate in on-call responsibilities for specific projects to ensure 24-hour coverage for case intake from investigative sites.

• Operate in a leadership role and assist in the development of program and departmental procedural documents.

• Prepare for and attend audits.

• Provide mentorship to less experienced staff members.

• Review regulatory and pharmacovigilance publications and information sources to remain updated on regulations, practices, procedures, and proposals.

• Maintain a medical understanding of relevant therapeutic areas and disease states.

• Review cases for quality, consistency, and accuracy, including peer reports.

• Coordinate routine project implementation, including Clinical Trials and Endpoint Assessment/Data Safety Monitoring Committees.

• Present at client and investigator meetings.

• Review metrics and consider budget implications.

⛳️ Requirements

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

• Over 5 years of previous experience providing the necessary knowledge, skills, and abilities to perform the role.

• An equivalent combination of appropriate education, training, and/or directly related experience may also be considered.

• In-depth understanding of pathophysiology and disease processes.

• Strong knowledge of relevant therapeutic areas for adverse-event processing.

• Excellent critical thinking and problem-solving skills; capability to evaluate and escalate issues appropriately.

• Proficiency in complex clinical study administration, including budget management and forecasting.

• Exceptional oral and written communication skills, including paraphrasing abilities.

• Strong command of English, with the ability to translate information into the local language when necessary.

• Computer literacy and capability to work with multiple databases.

• Proficient in Microsoft Office applications, including Outlook, Word, and Excel.

• Comprehensive understanding of global regulatory requirements and compliance with procedural documents and regulations.

• Ability to manage and prioritize diverse tasks while meeting strict deadlines with minimal supervision.

• Strong attention to detail.

• Ability to maintain a positive and professional demeanor in challenging situations.

• Capability to work effectively within a team to achieve a common goal.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Standard Monday–Friday work schedule.

• Potential on-call responsibilities for 24-hour case-intake coverage.

• Occasional domestic and/or international travel.

• Mentoring and professional development through collaborative and developmental opportunities.