Safety Specialist
hace 4 semanas
At Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a key member of our team, you'll play a vital role in bringing our mission to life by delivering high-quality Pharmacovigilance (PV) services.
Key Responsibilities:
- Perform day-to-day PV activities, including collection, monitoring, assessment, evaluation, research, and tracking of safety information.
- Collaborate with project team members, client contacts, investigators, and adverse event reporters to ensure seamless communication and timely resolution of issues.
- Develop and maintain procedural documents, prepare for and attend audits, and mentor less-experienced staff to ensure compliance with regulatory requirements.
- Stay up-to-date on current regulations, practices, and proposals by reviewing regulatory/pharmacovigilance publications and information sources.
- Review cases entered for quality, consistency, and accuracy, including review of peer reports.
Requirements:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- Thorough understanding of pathophysiology and the disease process.
- Solid understanding of relevant therapeutic areas as needed for processing adverse events.
- Excellent critical thinking and problem-solving skills with the ability to evaluate and escalate appropriately.
- Proficient in sophisticated clinical study administration, including budget activities and forecasting.
- Excellent oral and written communication skills, including paraphrasing skills.
- Good command of English and ability to translate information into local language where required.
- Computer literate with the ability to work within multiple databases.
- Proficient in Microsoft Office products (including Outlook, Word, and Excel).
- Thorough understanding of the global regulatory requirements and the importance of compliance with procedural documents and regulations.
- Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision.
- Strong attention to detail.
- Ability to maintain a positive and professional demeanor in exciting circumstances.
- Ability to work effectively within a team to attain a shared goal.
What We Offer:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
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