Senior Drug Safety Specialist – Night Shift

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

📋 Description

• Execute and potentially supervise daily Pharmacovigilance operations within a highly regulated environment.

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

• Collaborate with project team members, client representatives, investigators, adverse event reporters, and third-party vendors.

• Engage in on-call responsibilities for specific projects to guarantee 24-hour case intake coverage.

• Function in a leadership role.

• Aid in the creation of program and departmental procedural documentation.

• Prepare for and participate in audits.

• Mentor junior staff members.

• Examine regulatory and pharmacovigilance publications and informational sources.

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

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

• Coordinate routine project implementation, encompassing clinical trials and post-approval activities.

• Present at client meetings while reviewing metrics and budget considerations.

⛳️ Requirements

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

• Over 5 years of relevant experience.

• Consideration may be given to a combination of appropriate education, training, and/or directly related experience.

• In-depth understanding of pathophysiology and disease mechanisms.

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

• Critical thinking and problem-solving abilities, with the capability to evaluate and escalate as necessary.

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

• Exceptional oral and written communication skills, along with proficient paraphrasing abilities.

• Good command of English and the ability to translate information into the local language when required.

• Computer literacy and proficiency in navigating multiple databases.

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

• Thorough knowledge of global regulatory standards and adherence to procedural documents and regulations.

• Capability 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.

• Effectiveness in working collaboratively within a team environment.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Occasional domestic and/or international travel.

• Reasonable accommodations for individuals with disabilities.

• Equal opportunity employment.