- Works independently to perform day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
- Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less expert staff. Reviews regulatory/pharmacovigilance publications and information sources t
- keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states. Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
- Responsible for routine project implementation and coordination (, Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.
- Thorough understanding of pathophysiology and the disease process
- Solid understanding of relevant therapeutic areas as the need arises for processing AEs
- 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 and 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
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Principal Safety Specialist - Cambridge, United Kingdom - Thermo Fisher Scientific
Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Summarized Purpose:
Performs and may oversee day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Optimally collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors.
Key responsibilities:
Keys to Success
Education and Experience:
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).
Knowledge, Skills and Abilities:
Benefits
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
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
