Lilly Director/Sr. Director - Principal Pharmacovigilance Physician in New York, United States
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Principal Pharmacovigilance Physician:
Remote working may be considered for a highly qualified and experienced individual not within commuting distance of our office in Manhattan NY.
The Global Safety and Pharmacovigilance team is responsible for all pharmacovigilance activities and deliverables including single case and aggregate safety monitoring, SUSARs reporting, contribution to benefit-risk assessment, risk management planning and strategy, and ensuring compliance with global regulatory requirements.
Clinical Development & Product Support:
Appropriately perform core signal detection activities and elevate program or portfolio issues and milestones with appropriate oversight.
Supports VP GS&PV leading signal detection activities for a product's emerging safety profile.
Lead Aggregate Safety Data Review Meetings in the review and evaluation of clinical data to support signal detection. Appropriately elevate issues impacting key SMT activities, milestones, and documentation as needed.
Execute strategy for signal evaluation (e.g., case-series, literature review, HA/ claims database). Partner with SMT Chair on the evaluation & management of signals emerging from any data source.
Authors the Safety Topic Review/ Signal Report and tracks signals for other means of communication.
Responsible for authoring of agency responses and regulatory documents such as aggregate reports, DSURs, dRMPs, RMPs and the Clinical Overviews.
Responsible for authoring of safety data queries including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries.
Assists with the safety surveillance review of adverse experience (AE) reports and with the development risk management plans (dRMPs).
Author the IB RSI table with guidance from safety physician and analyze data and prepare documentation to support the RSI section of the IB updates for assigned products.
Perform the review and evaluation of ADRs/ SARs for inclusion in the IB ADR/RSI sections, including presentation to SMT to ensure alignment.
Working knowledge of product goals, strategy, drug development stage milestones, partnership agreement & HA commitments.
Liaison with Global Case Processing Teams and case processing Physicians as appropriate to clarify appropriate information required for case processing. Participation in project teams, including on-time delivery of assigned responsibilities.
Vendor oversight activities for assigned products: Product portfolio subject matter experts. Operational management activities for teams and vendors, including vendor meetings, monitoring quality of ICSRs.
Department Activities :
Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
Support hiring & orientation, process improvement and cross-functional initiatives including SOPs.
Builds cross functional relationships with SMT membership and stakeholders.
Facilitate the submission process for regulatory documents and publications.
Lead the quality assurance of prepared responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences reported with our developmental products.
Mentor clinical scientists in conjunction with the safety team, work to obtain information to further clarify AE reports received. This could include, but is not limited to, classification of reports and follow-up phone calls for AEs of special interest.
Serve as a functional area representative, providing oversight, management, and presentation of program data.
Assist with manuscripts for submission to peer reviewed journals, poster and /or oral presentations on the safety profile of assigned products and the guidance of such presentations through the internal clearance process.
Doctor of Medicine or Doctor of Osteopathy. Must be board eligible or certified in a medical specialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification.
Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
Previous pharmaceutical experience considered a plus
Safety and gene therapy PV experience beneficial
This position requires demonstrated leadership skills, independent programmatic support, excellent writing and verbal communication skills, problem solving ability and analytical skills. Independently able to utilize pharmacovigilance computer software programs to assist with data capture
Proficiency with Microsoft program package is required with data management quality assurance and compliance experience.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).