EVERSANA
Location
India | India
Job description
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 us!
Across 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
OUR CULTURAL BELIEFS
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
· Assume responsibility for management of client and client products.
· Serve as a resource for pharmacovigilance team on the procedures and processes for adverse event processing and aggregate reports for the client.
· Act as a company liaison with client to manage all issues related to services provided by EVERSANA PV
· Manage required training to the PV team
· Monitor timelines of the PV project and key performance indicators (KPI)
· Monitor the project budget and alert management if updates to the Statement of Work are required.
· Address any quality issues with the client.
· Lead the PV team on any changes to the client's requirements.
· 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.
· Conduct periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision.
· In addition to case management projects, this individual may also participate in the development of other EVERSANA-PV and client documents such as signal trending/detection reports, aggregate reports, safety management plans, standard operating procedures, and work instructions.
· May perform active follow-up via telephone contact with consumers and health care
professionals for the client projects.
· May work with client Clinical Research, sometimes in a lead capacity, regarding Safety Data Exchange Agreements (SDEA).
· Lead team members, e.g., Drug Safety Coordinators, Drug Safety Associates, to facilitate efficient case processing
· 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:
· 5% Travel (% or number of days)
· 45 Hours (Hours per week, days of the week)
The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.
An individual in this position must be able to successfully perform the expectations listed above.
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.
· BS degree in a life science discipline (e.g., pharmacy, nursing) is preferred
· At least 6 years of relevant experience, which includes 3 years in drug safety
· Broad knowledge of domestic and international drug safety regulations, industry practices and standards
· Strong attention to detail, teamwork, and initiative
· Strong understanding of drug development, drug safety reporting, as well as an appreciation for the importance of regulatory compliance
· Excellent working knowledge of MedDRA and WHODRUG coding dictionaries
· Familiarity with FDA, EMA, Health Canada and international adverse event reporting regulations per ICH guidelines
PREFERRED QUALIFICATIONS:
· Must be quality oriented and demonstrate consistent attention to detail
· Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
· Must have good planning and organizational skills
· Understanding of medical terminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus
· Knowledge of relevant software including safety database and Microsoft Office
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