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 create a draft narrative of the event(s) based on the description of the case provided by the reporter using a standard narrative construction guide; apply basic rules of grammar to improve the narrative content. Use judgment to decide what information should be included in the narrative to adequately and concisely describe the nature and course of the event.
- Independently formulate follow-up information requests.
- May perform active follow-up 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:
- <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
- 2+ years of relevant experience, which includes 1 year 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 and international adverse event reporting regulations per ICH guidelines.
- Understanding of medical terminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus.
- 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
- Knowledge of relevant software including safety database and Microsoft Office
PREFERRED QUALIFICATIONS:
- Positive Attitude and Energy – Exhibits an upbeat attitude and a genuine interest in others. Energizes others and heightens morale through her/his attitude.
- Communication Skills – Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate.
- Innovator – Transforms creative ideas into original solutions that positively impact the company’s performance.
- Highly Principled – Proves to be a professional of unquestionable integrity, credibility and character who demonstrates high moral and ethical behavior.
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