Drug Safety Specialist – Day Shift

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

📋 Description

• Execute daily pharmacovigilance tasks within a highly regulated setting.

• Gather, monitor, evaluate, research, and track safety-related information.

• Conduct data entry, coding, adverse event assessments, case reviews, follow-ups, report tracking, and regulatory submissions.

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

• Aid in departmental and project-specific procedures and processes.

• Prepare for and participate in audits, kick-off meetings, and investigator meetings.

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

• Review pharmacovigilance literature and information sources to stay updated on regulations, practices, procedures, and proposals.

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

• Assess cases and peer reports for quality, consistency, and accuracy.

• Prepare and uphold regulatory safety reports.

• Assist with routine project implementation and coordination, including clinical trials and safety monitoring committees.

• Present information at client and investigator meetings.

• Review metrics and budget considerations.

• Mentor junior staff members.

⛳️ Requirements

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

• At least 2 years of prior experience in pharmacovigilance case processing, triage, and/or peer review.

• Equivalence through a mix of suitable education, training, and/or directly related experience may be considered.

• General understanding of pathophysiology and disease processes.

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

• Strong critical thinking and problem-solving abilities.

• Excellent oral and written communication skills, including effective paraphrasing.

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

• Competent in computer use and capable of working within multiple databases.

• Prior experience with Microsoft Office applications, including Outlook, Word, and Excel.

• Familiarity with procedural documents and regulatory compliance.

• 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.

• Ability to work effectively within a team to achieve shared objectives.

• Willingness to travel domestically and/or internationally as needed.

🏝️ Benefits

• Global team environment emphasizing collaboration and development.

• Reasonable accommodations available for individuals with disabilities.

• Commitment to equal opportunity employment.