Client Dedicated Safety Writer II
Employer · ThermoFisher Scientific
Other health professional
Legal specialistDaytimeFull-timeRemote
Join Us as a Safety Writer II -- Make an Impact at the Forefront of Innovation. As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in patient safety. You will be responsible for the planning, coordination, and delivery of safety writing services for multiple clinical trial and/or marketed product projects within a highly regulated pharmacovigilance environment.
Tasks
- Conducts data review, authoring, and quality review tasks on, and project manages a wide range of clinical trial and marketed product safety writing deliverables.
- Uses multiple company and client systems and interacts with project team members and clients.
- Operates in a lead capacity, serving as the primary point of contact for assigned safety writing deliverables.
- Ensures that assigned safety writing and project management tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.
- Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices and procedures.
- Performs routine project implementation and coordination activities for assigned safety writing projects.
Conditions & benefits
Global Team EnvironmentJoin a global team that values passion, innovation, and a commitment to scientific excellence.Collaboration and DevelopmentWork in an environment where collaboration and development are part of the everyday experience.
Requirements
- 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)
- Comprehensive knowledge and experience of ICH and US aggregate safety reporting formats relating to clinical trials and/or marketed products
- Thorough attention to detail; strong data interpretation and medical-scientific writing skills
- Strong critical thinking and problem solving skills with ability to evaluate and escalate appropriately
- Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
- Strong oral and written English language communication skills, including paraphrasing skills
- Solid computer skills with the ability to work within multiple systems; proficient in use of MicrosoftOffice products (including Outlook, Word, and Excel)
- In-depth understanding of the global regulatory requirements pertaining to pharmacovigilance and the importance of and compliance with procedural documents and regulations