Lexicon Pharmaceuticals is currently recruiting for an agile, results focused Senior Medical Director/Drug Safety Physician to join our team in Basking Ridge, New Jersey.
The Medical Director/Senior Medical Director (Drug Safety Physician) is accountable for the medical safety oversight of assigned products across the product lifecycle including review and analysis of safety information from all sources, development of risk management plans and assessment of benefit risk profile of the product. This position is responsible for performing activities in accordance with FDA regulations, ICH guidelines and applicable SOPs in collaboration with the other departments to ensure effective management and communication of the benefit/risk profile of the product.
Key Responsibilities include but will not be limited to:
Leading Medical Safety Teams for assigned products in the evaluation, communication and management of safety signal and escalating important issues to Senior Management as appropriate.
Overseeing safety aspects for clinical studies and working with clinical counterparts as needed to ensure appropriate study conduct from a medical safety perspective.
Providing medical assessment of individual case safety reports (ICSRs) including causality assessment, determination of expectedness, identification of events of interest
Authoring relevant sections and conclusions of product safety profile for aggregate reports.
Contributing to regulatory response documents
Managing external PV consultants and CROs and providing them with strategic leadership and oversight of safety monitoring
Contributing (writing, editing and reviewing) to the safety section of New Drug Application (NDA) submission documents and the clinical study reports
MD or DO. Board Certified/Board Eligible or equivalent with a 5 - 7 years experience in the pharmaceutical industry and at least 3 years focused on pharmacovigilance
Expertise in global pharmacovigilance and clinical safety regulations and guidelines
Ability to objectively interpret, analyze and communicate medical and scientific data
Experience with MedDRA and drug safety databases, such as ARISg
Strong communication skills both written and verbal
Ability to develop and maintain collaborative relationships
For additional information about Lexicon and its programs, please visit www.lexpharma.com.
An Equal Opportunity Employer - Females, Minorities, Veterans, and Disabled.
Lexicon Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test, background check and verification of credentials before beginning employment.
The Physician Payment Sunshine Act (Sunshine Act) as well as several state laws require Lexicon to report any transfers of value, including payments made to reimburse interview-related expenses, for candidates who are US-licensed physicians. U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) on an annual basis and CMS shall post submitted data on its public database.
Lexicon Pharmaceuticals is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for people with serious, chronic conditions. Using a patient driven approach, we are working to discover and develop innovative medicines to safely and effectively treat disease and improve patie...nt lives.
Our world class research and development and commercialization teams are located in Basking Ridge, New Jersey and The Woodlands, Texas. Lexicon employees are inspired by the idea that their work can improve patients' lives and we know that our employees are important to the success of our mission. We are dedicated to making Lexicon a great place to work by providing employees with the benefits, services, and programs which will allow them to reach their full potential.
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