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.  

THE POSITION: This position supports 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 and other 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 and as a Subject Matter Expert (SME) in various aspects of Pharmacovigilance.
• 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 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.
• Exhibit expertise on all assigned client products within a therapeutic area and provide inputs to Org level requirements on functional aspects
• 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:

• Travel (<5% or number of days)
• Hours (45 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
• 8-10 years of relevant experience, which includes 7+ 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

PREFERRED QUALIFICATIONS:

• Positive Attitude and Energy – Exhibits an upbeat attitude, a genuine interest in others, and a sense of humor. 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.

OUR CULTURAL BELIEFS

Patient Minded I act with the patient’s best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and hold myself accountable.

Embrace Diversity I create an environment of awareness and respect.

Grow Talent I own my development and invest in the development of others. 

Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

Communication Matters I speak up to create transparent, thoughtful, and timely dialogue.

Always Innovate I am bold and creative in everything I do.

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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