At EVERSANA, our integrated life sciences compliance including the PV team is taking a leading role in helping some of the most scientifically advanced BioPharma and research companies around the world to innovate novel therapies for rare, ultra-rare and a range of critical therapeutic areas including Oncology, Neurology, Immuno-oncology, Immunology etc. The most important aspect of this position is to enable EVERSANA’s customers with solutions that strike balance between the reactive side of PV, i.e., safety case processing and regulatory reporting and the proactive side of PV, i.e., predictive safety using safety data sciences, advanced data analytics and cutting-edge technology solutions to meet the demands of the innovation and transformation our customers expect from us. This is a leadership role within EVERSANA PV compliance team reporting directly into the SVP of Safety. This individual will be embraced with the responsibility of supporting EVERSANA to become the most forward-looking thought leader and a leading solution provider of PV services meeting the current and future needs of its customers helping them deliver better and safer drugs to the patients. This person will also collaborate very closely with other leaders with in the EVERSANA Compliance Business Unit (Regulatory, Quality, Medical Affairs) to further strengthen the vision of integrated compliance services platform. In addition, this person will also work closely with leaders in other Business Units including Patient services, Market Access, Engage, Field solutions, 3PL, Data & Analytics and Management consulting for driving integrated opportunities where EVERSANA takes end to end accountability right from the early/late Phase 3 to managing the entire life cycle of the product.
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.
Communication Matters I speak up to create transparent, thoughtful and timely dialogue.
Own It I hold myself and others accountable for results.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
EVERSANA customers are working on addressing unmet medical needs using advanced techniques and delivery models such as cell and gene therapies, tissue-engineered products, and combination products, evolving in a complex and dynamic scientific and global regulatory environment. So, it’s an ongoing endeavor at EVERSANA to build on the knowledge of safety and pharmacovigilance for small molecule and biologic- based medicine to understand special safety considerations for these unique new products. Our ability to apply best practices in current daily operations while anticipating coming changes associated with new therapies and technologies is key to putting safe products on market and optimizing benefits to patients. The key responsibilities of this role are:
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.