As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Hiring for Safety Specialist I (Remote): This permanent, remote opportunity can be worked anywhere in the U.S.
To support case follow up activities for post approval and some clinical trial reported cases. This will primarily be telephonic calls to health care providers and consumers. In addition, follow up support via email, fax and postal will be required. Argus safety data base experience is required. Experience working on post approval projects in US required.
Job Overview:
- Receive information, record and reporting Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call, email, fax etc.
- Assist in producing queries of safety data for clients as appropriate
- Perform and support different activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources
- Assume responsibility for quality of data processes
- Provide input for monthly status reports.
- Create and revise training materials based on procedural, system, and regulation updates
- Responsible in conducting trainings and checks the effectiveness of the trainings as required
- Assist in the generation and maintenance of the PSS metrics.
- Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Possess knowledge of other procedural documents, e.g., SOPs, and how they impact safety.
- Build and maintain good PSS relationships across functional units.
- Demonstrate role-specific Core Competencies on a consistent basis.
- Assist in the preparation of client meetings and liaise with clients where appropriate.
- In addition, candidate must have experience with the receipt and processing of adverse events
- Entry of safety data onto adverse event database(s) and tracking systems
- Review of adverse events for completeness, accuracy and appropriateness for expedited reporting
- Write patient narratives
- Code adverse events accurately using MedDRA
- Determine expectedness/listedness against appropriate label
- Identifies clinically significant information missing from initial reports and ensures its collection
Qualifications (Minimum Required):
- Health Care Provider Degree required
- Associate's Degree + 3 years of safety experience
- Associate’s Degree RN + 3 years of safety experience
- BS/BA + 3-4 years of minimum safety experience
- MS/MA + 3 years of safety experience
- PharmD + 3 years safety experience
US Pay Range: $75,000 - $84,000 USD
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here. Application deadline is November 15, 2024.
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Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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