EVERSANA

Sr Medical Director/Associate Vice President, Safety Science (Remote - US)

Job Locations US-CA-Emeryville
Job ID
2020-5326
# of Openings
1
Category
Compliance and Regulatory

Overview

THE POSITION:


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.

Responsibilities

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:

 

  • Actively participate in building and delivering the overall vision of EVERSANA’s PV services and the overall integrated compliance services. Proactively work internally and externally to uncover market unmet needs and building right solutions
  • Provide strategic and tactical leadership from a medical standpoint throughout the PV services paradigm (safety case processing, signal and risk management, aggregate reporting, safety-related discussions with clinical investigators, IRBs/ECs, Data Monitoring Committees/regulatory authorities and safety data science)
  • Use his/her network to help expand the PV business
    Work with CMO’s, Head of R&D’s, Safety leaders and others to understand their specific safety needs associated with their respective research areas and provide them right guidance and solution
  • Lead the team of Medical experts globally at EVERSANA that are involved in
    • Reviewing and analyzing the safety information, assisting clients with the safety data, compliance with PV legislation and guidance, and all medical aspects of pharmacovigilance
    • Medical assessment of SAE reports, including case narrative accuracy, MedDRA coding, medically relevant queries, expectedness, causality, and reportability
    • Provide pharmacovigilance strategic advice and medical writing
      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 hours on call medical monitoring
    • Changing global pharmacovigilance and regulatory legislation, guidance, and inspection finding trends
  • Lead signal management and benefit risk evaluation (i.e., PBRER, RMP)
  • Create a thought leadership platform and provide medical and pharmacovigilance leadership at safety leadership meetings, conferences and other consortiums
  • Medical lead in meetings with regulatory authorities, study investigators, IRBs/ECs and data monitoring committees
  • Provide clients leadership and team mentorship
  • Work collaboratively with internal EVERSANA groups in handling multiple complex tasks against regulatory and business timelines and provide teams with insight and leadership
  • Establish team goals which support EVERSANA’s corporate objectives and ensure that staff has aligned goals

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

 

  • MD
  • Thought leader in the PV domain
  • Well rounded experience in all aspects of PV i.e. safety operations, Signal and risk management, safety data sciences and advance analytics
  • Prior leadership experience in leading global safety team or global medical experts
  • A proven leader with vast industry network
  • Minimum 15 years of Pharmacovigilance experience with exposure into rare, ultra-rare segment across key therapeutic areas like Oncology, Neurology, Immuno-oncology, Immunology
  • Well versed with the technological advancement in PV including advanced data analytics, application of automation and artificial intelligence and safety data science
  • Must be a hands-on leader with prior experience in:
    • Proficiency in trial and post-market drug and device safety information processing and analysis
    • Experience in the clinical and drug development process in a pharmaceutical/biotechnology company and preparation risk management plans, aggregate reports and company core safety information highly desirable.
    • Knowledge of and ability to interpret and apply international safety regulations.
    • 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.
  • Other soft skills:
    • 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.

 

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