Drug Safety Associate
1 week ago
At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We're fueled by our vision to create a healthier world.
How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry.
We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies.
Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join usAcross our growing organization, we embrace diversity in backgrounds and experiences.
Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry.
We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building.We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve.
We are EVERSANA.Job Description:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams.
These results are achieved by:
- Works closely with the Drug Safety Management and/or assigned Project Lead to facilitate and meet client project deadlines.
- Provides support to other (Sr.) Drug Safety Associate staff to efficiently manage workload and ensuring timely reporting to Regulatory Authorities and to others as required.
- In addition to case management projects, this individual may also participate in the development of other EVERSANA-PV and client documents such as aggregate reports, safety management plans, standard operating procedures, and work instructions.
- Participation in and oversight of EVERSANA-PV client case processing activities.
- Collection of Adverse Events (AEs) from all sources, tracking of cases through case processing activities, and coordinating workflow activities to promote accurate reporting and efficient time management.
- Independently assess expectedness, seriousness, and causality in accordance with regulatory guidelines and product reference safety information.
- Independently code adverse events in MedDRA using clinical judgment and medications to WHODRUG.
- Perform a Quality Control check for completeness, accuracy, and consistency of information in the safety database and on regulatory reporting forms (e.g., MedWatch, CIOMS I).
- Independently formulate followup information requests.
- May perform active followup via telephone contact with consumers and health care professionals.
- May work with client Clinical Research, sometimes in a lead capacity, regarding information exchange and safety exchange agreements.
- Ensure regulatory compliance with timelines for individual expedited case report submissions and provide assistance and timely delivery of information for aggregate reports, ad hoc report compilations, and other regulatory documents as requested.
- Interact with the client and/or other stakeholders for the purpose of safety data collection, data reconciliation, etc.
- Develop expertise on all assigned client products within a therapeutic area.
- Understand applicable corporate and global regulations, guidelines, SOPs, and writing practices.
- Lead team members, e.g., Drug Safety Coordinators, Drug Safety Associates, to facilitate efficient case processing.
- Conduct periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision.
- All other duties as assigned
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position._
EXPECTATIONS OF THE JOB:
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