Senior Drug Safety Associate
2 months ago
THE POSITION:
This position supports of the client Pharmacovigilance (PV) Department as both a team member and individual contributor in the processing and analyses of safety data from clinical trials and spontaneous post-marketing reports.
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 PV Management and/or assigned Project Manager to facilitate and meet client project deadlines.
- Provides support to other PV 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, standard operating procedures, and work instructions.
- Participation in 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
- Independent triage of AEs to determine reportability not to exclude collaboration with relevant team members as may be required in order to establish an accurate clinical assessment of the case and process information on reported adverse drug and device experiences, including accurate data entry in the client safety database with minimal supervision
- 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 queries.
- May work with EVERSANA Project Lead regarding information exchange and safety data exchange agreements
- Ensure regulatory compliance with timelines for individual expedited case report submissions
- 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.
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
- 5 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 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
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.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.
From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.
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