Senior Drug Safety Specialist – Night Shift
Posted 21 days ago
You'll complete your application on Thermo Fisher Scientific's career site.
About the Role
This senior-level pharmacovigilance role is vital to a fast-moving, strictly regulated setting. As a member of an international team, you will help gather, evaluate, and administer safety information to ensure therapeutic initiatives and clinical studies adhere to top-tier safety and compliance protocols. This position suits professionals who excel in team-based settings where accuracy and regulatory conformity are essential for enhancing patient outcomes worldwide. In this capacity, you will act as a primary subject matter expert for investigators, project groups, and outside partners. You will also have the chance to shape internal processes, guide junior staff, and engage in significant strategic work, including project execution and audit preparation. This is a perfect match for seasoned experts aiming to apply their extensive medical and regulatory expertise within a mission-focused, structured pharmaceutical services firm.
Requirements
- You need a bachelor's degree or a comparable mix of work experience and education, along with at least five years of specialized professional experience.
- You must possess extensive knowledge of disease processes, pathophysiology, and the handling of adverse events in particular therapeutic domains.
- You should demonstrate advanced critical thinking, competence in managing intricate clinical study workflows, and a strong command of international regulatory standards.
- You need to be proficient in database and computer applications, specifically Microsoft Excel, Word, and Outlook, and possess high-level English skills in communication and paraphrasing.
- You must be a self-directed professional capable of working with minimal oversight, managing multiple priorities under tight deadlines, and maintaining professional conduct while collaborating with global investigators and teams.
Responsibilities
- You will manage and supervise daily pharmacovigilance activities, including the gathering, tracking, monitoring, and analysis of safety data.
- You will partner closely with vendors, clients, and project teams, while participating in an on-call rotation to facilitate 24-hour safety intake coverage.
- You will verify case quality and uniformity, manage clinical trial assignments, and help author departmental standard operating procedures.
- You will provide training to junior staff, represent the department in client and investigator forums, and assist in audit preparation.
- You will maintain a comprehensive grasp of pertinent therapeutic areas and keep up-to-date with shifting regulatory requirements.
Benefits & Perks
- This is a full-time, 100% remote position.
- You will generally operate on a Monday through Friday schedule, with expectations for on-call participation and periodic domestic or international travel.
- You will benefit from significant opportunities for mentorship and professional growth in a cooperative global setting.
Note: This listing is summarized and paraphrased by WorkNow from a publicly posted role. For the original wording and full details, please refer to the employer's official posting.
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