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:

The most important aspect of this position is to provide medical expertise in the review and analysis of safety information, assisting clients with the safety data, compliance with pharmacovigilance (PV) legislation and guidance, and all medical aspects of PV. ln addition, this individual is adept in safety-related discussions with clinical investigators, lRBs, lECs, Data Monitoring Committees and regulatory authorities. This position may also participate in the review of individual SAE reports, preparation of medical commentary and analysis, and preparation of safety evaluations in aggregate periodic reports. This position provides supervisory leadership and performance management to PV medical reviewers.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Proficiency in trial and post market drug and device safety information processing and analysis

· Provide medical expertise in the review and analysis of case and aggregate safety information.

· Provide clients with PV legislation and guidance information without the need for supervision

· Conduct safety activities in compliance with PV and device safety legislation and guidance without the need for supervision

· Provide pharmacovigilance strategic advice and medical writing

· Business development as directed

· Self-education on changing global pharmacovigilance and regulatory legislation, guidance, and inspection finding trends

· Provide medical expertise for clinical protocol development and medical monitoring of clinical trials

· Creation of the safety section in protocols, informed consents, reference safety information and periodic reports (i.e., DSUR)

· 24 hour on call medical monitoring

· Lead signal management and benefit risk evaluation (i.e., PBRER)

· Provide medical and pharmacovigilance leadership at safety leadership meetings

· Medical lead in meetings with regulatory authorities, study investigators, lRBs, lECs and data monitoring committees

· Lead medical assessment of SAE reports, including case narrative accuracy, MedDRA coding, medically relevant queries, expectedness, causality, and reportability

· Create or review the Analysis of Similar Events

· Lead medical reviewers to facilitate efficient and accurate case review

· This position will provide clients leadership and junior staff mentorship

· Work collaboratively with internal EVERSANA groups in handling multiple complex tasks against regulatory and business timelines and provide teams with insight and leadership

· Tactical organizational leadership

· Setting clear direction, effective plans and measurable outcomes

· Ensuring work is accomplished effectively by managing employee performance, work processes and other resources

· Engaging employees to maximize their discretionary effort

· Developing a pipeline of excellent talent to fill future business needs

· Plans, organizes and coordinates various projects, programs and services.

· 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.

· MD or equivalent (D.O., M.B.B.S, etc.) or comparable education. A minimum of 5 years pharmacovigilance experience

· Demonstrated competence in collecting, analyzing, and reporting safety data in compliance with regulations.

· Experience preparing investigational and post-marketing regulatory reports. Experience developing data analyses and medical evaluation of safety data. Experience with pharmacovigilance related computer systems and programs. Experience managing people and teams are preferred.

· Excellent leadership skills.

· Willingness to mentor others. Detail oriented.

· Excellent interpersonal and organizational skills. Excellent written and verbal communication skills.

· Ability to work proactively.

· Excellent problem-solving skills.

· Good communications skills required.

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.

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 empower others to act now.

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.

Embrace Diversity I create an environment of awareness and respect.

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

Own It I hold myself and others accountable for results.

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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