Pharmacovigilance Lead Specialist
hace 2 semanas
We are seeking a highly skilled Pharmacovigilance Lead Specialist to join our team at Thermo Fisher Scientific. As a key member of our Pharmacovigilance team, you will be responsible for overseeing day-to-day activities within a highly regulated environment and driven by strict timelines.
Key Responsibilities- You will work independently to perform day-to-day Pharmacovigilance activities, including collection, monitoring, assessment, evaluation, research, and tracking of safety information.
- In a lead capacity, you will provide assistance in the development of program and departmental procedural documents, prepare for and attend audits, mentor less experienced staff, and review regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, procedures, and proposals.
- You will also maintain medical understanding of applicable therapeutic areas and disease states, review cases entered for quality, consistency, and accuracy, including review of peer reports, and be responsible for routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget considerations.
- A Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience that provides the 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 the need arises for processing Adverse Events.
- Excellent critical thinking and problem-solving skills with ability to evaluate and escalate appropriately.
- Proficient at 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.
We offer competitive remuneration ($95,000 - $120,000 per year), an 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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