Senior/Principal Drug Safety Specialist
Posted 3 days ago
You'll complete your application on Thermo Fisher Scientific's career site.
About the Role
This Senior or Principal-level role focuses on executing and managing vital pharmacovigilance tasks in a strictly regulated clinical research setting. You will serve as a key contributor to patient protection by gathering, tracking, analyzing, and judging intricate safety data. You will support scientific quality by staying highly informed on specific therapeutic fields and pathologies, ensuring that all projects adhere to strict compliance and excellence benchmarks.
Requirements
- You need at least a bachelor’s degree or an equivalent academic credential and a minimum of five years of industry experience.
- You should demonstrate a comprehensive grasp of pathophysiology, disease mechanics, and the therapeutic contexts relevant to adverse event management.
- You must exhibit high-level critical thinking, problem-solving skills, and expertise in administering clinical studies, including financial forecasting and budget management.
- You must be computer proficient, specifically with Microsoft Office and database software, and possess a high level of fluency in the English language.
- You are expected to handle diverse assignments independently under tight time constraints, maintain precise attention to detail, and display professionalism during difficult situations.
Responsibilities
- You will oversee the daily functions of drug safety initiatives, including gathering and evaluating safety documentation and joining an on-call rotation to facilitate around-the-clock case intake.
- You will spearhead the creation of departmental protocols, guide junior team members, and audit cases for precision, uniformity, and accuracy.
- You will manage preparations for audits, oversee the execution of standard clinical trial tasks, and track project metrics alongside budgetary needs.
- You will coordinate with project groups, clients, investigators, and external partners, occasionally delivering presentations during client or investigator sessions.
Benefits & Perks
- You will have substantial chances to work with a global team and grow professionally.
- You will contribute significantly to scientific progress and patient well-being, with the possibility of both domestic and overseas travel.
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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