Drug Safety Specialist – Day Shift

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

📋 Description

• Conducts daily pharmacovigilance (PV) activities.

• May engage in on-call responsibilities for specific projects to guarantee 24-hour coverage for case intake from investigative sites.

• Reviews regulatory and pharmacovigilance publications as well as information sources to stay informed about current regulations, practices, procedures, and proposals.

• Maintains a comprehensive medical understanding of the relevant therapeutic area and associated disease states.

• Evaluates cases entered for quality, consistency, and accuracy, including the review of peer reports.

• Prepares and oversees regulatory safety reports.

• Assists in the routine implementation and coordination of projects (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee).

• Provides mentorship to less experienced personnel.

⛳️ Requirements

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

• Prior experience that equips the candidate with the knowledge, skills, and abilities to perform the role (at least 2 years in a comparable position).

• General understanding of pathophysiology and the disease process.

• In-depth knowledge of relevant therapeutic areas necessary for processing adverse events (AEs).

• Strong critical thinking and problem-solving abilities.

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

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

• Computer literate with the competence to navigate multiple databases.

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

• Awareness of the significance of procedural documents and regulatory compliance.

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

• High attention to detail.

• Capacity to maintain a positive and professional attitude in challenging situations.

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

🏝️ Benefits

• Health insurance.

• Flexible work arrangements.