Sr. Director, Safety Operations and Infrastructure
Position: Sr. Director, Safety Operations and Infrastructure
Reports to: VP, Global Patient Safety and Risk Management
Location: Brisbane, CA or Raleigh, North Carolina
Reporting to the VP, Global Patient Safety and Risk Management, the Senior Director, Safety Operations and Infrastructure is accountable for developing and overseeing all pharmacovigilance operational processes and activities, in-house and with vendors. The Senior Director will lead the development, implementation, and continuous improvement of technical safety infrastructure for Aimmune to support both clinical trial and post-marketing safety
- Accountable for identification, initiation, development and implementation of PV process improvements, tools, systems and procedures to ensure quality and consistency in safety operations, data output, studies and programs.
- Responsible for implementing and maintaining safety database, safety data standards, safety data quality, case processing and follow-up with vendor support
- Responsible for working with the safety medical team to implement and support appropriate analysis tools for safety data from study and post-marketed environments
- Act as project manager for aggregate reports and assure appropriate, timely and accurate data outputs from the safety database
- Lead the budget planning for the safety operations function and report on ongoing budget initiatives
- Serve as subject matter expert (SME) for audits and inspections as well as ensure preparedness for all safety-related documentation to be filed properly for inspection
- Build and lead a team of safety operations specialists to meet the needs of the growing organization
Qualifications / Requirements:
- Advanced degree in life sciences, nursing, pharmacy or medicine; PhD, PharmD, BsN
- 10+ years of experience in global pharmacovigilance operations for a biotechnology or pharmaceutical company in both clinical trial and post marketing environments.
- 6 years or more years of functional management experience overseeing PV staff
- A working understanding of drug safety databases (Argus), safety coding dictionaries, technical requirements, and analytic tools
Preferred Experience, Special Skills, Knowledge:
- Thorough understanding of the drug development process
- Thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, GPV and GCP
- Experience in ICSR management and reporting, aggregate reporting
- Vendor management and oversight experience
- Effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
- Excellent people management skills
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc. is a biopharmaceutical company that aspires to become the global leader in developing curative therapies and solutions for patients with food allergies. With a mission to improve the lives of people with food allergies, Aimmune is developing and commercializing oral treatments for potentially life-threatening food allergies. The Company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. For more information, please visit www.aimmune.com.
Aimmune is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.