Drug Safety Specialist

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

📋 Description

• Conducts daily pharmacovigilance (PV) operations.

• May engage in on-call responsibilities for designated projects to ensure 24-hour availability for case intake from investigative sites.

• Reviews publications and information in regulatory/pharmacovigilance to remain informed on current regulations, practices, procedures, and proposals.

• Maintains a solid understanding of relevant therapeutic areas and disease conditions.

• Assesses entered cases for quality, consistency, and accuracy, including analyzing peer reports.

• Prepares and updates regulatory safety reports.

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

• Provides mentorship to less experienced team members.

⛳️ Requirements

• Bachelor's degree or an equivalent level of relevant formal education/vocational qualification.

• Prior experience that equips the individual with the necessary knowledge, skills, and abilities to fulfill the role (minimum of 2 years is comparable).

• General comprehension of pathophysiology and the disease process.

• In-depth knowledge of pertinent therapeutic areas required for adverse event (AE) processing.

• Strong critical thinking and problem-solving capabilities.

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

• Proficient in English and capable of translating information into the local language as needed.

• Computer literate with proficiency in navigating various databases.

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

• Awareness of the significance of and adherence to procedural documents and regulations.

• Ability to manage and prioritize a variety of tasks while meeting strict deadlines with minimal supervision.

• Strong attention to detail.

• Capacity to maintain a positive and professional demeanor under challenging circumstances.

• Ability to collaborate effectively within a team to achieve common objectives.

🏝️ Benefits

• Reasonable accommodations for individuals with disabilities.

• An engaging work environment.

• Participation in the job application or interview process.