Associate Director/Director Pharmacovigilance
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, Repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer (NSCLC) and advanced solid tumors. Turning Point Therapeutics is driven to develop therapies that mark a turning point for patients in their cancer treatment.
Under the guidance of the Sr. Director of Pharmacovigilance.
Essential Duties and Responsibilities
- Manage relationships with internal and external vendors, as the safety contact, supporting safety reporting to ensure that compliance and safety reporting requests are being met, including participation in periodic audits, and contributing to the development of correction plans
- Plan, and provide oversight for the timely development of safety-related regulatory documentation including DSURs, IND annual reports, or other global reports and assist in the responses to questions from regulatory agency or IRB/EC on safety-related issues
- Collaborate in the development and risk communications to health care professionals, investigators, regulatory agencies
- Support the signal management process through workflow closure, ensuring that signals are tracked, and recommended actions completed in a timely manner
- Assist in the management of pharmacovigilance inspections
- BS/BA or higher in a health-related area (i.e. RPH, RN/BSN, PharmD) and at least 5 continuous years in the pharmaceutical industry or a clinical research organization, with experience in drug safety operations, pharmacovigilance, and/or risk assessment.
- Strong working knowledge relevant to safety monitoring and case management, use of ARGUS, MedDRA/WHO coding, and experience in preparation of aggregate reports for investigational drugs (DSURS, IND Annual reports) and/or post-marketing reports (PSUR/PBRER, PADER).
- Current knowledge of good pharmacovigilance practice.
- Proficiency in standard Microsoft Office programs (Word, Excel, and Outlook) is required.
- Applicants must have work authorization to work in the US.
EEO & Employment Eligibility
Turning Point Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Turning Point Therapeutics also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Turning Point Therapeutics is an E-Verify employer.