Pliant is a late-stage biopharmaceutical company focused on the discovery, development and commercialization of novel and potential first-in-class and next-in-class therapeutics for the treatment of fibrotic lung diseases. As the leader in integrin biology and with our deep understanding of fibrosis biology, we’re developing small molecule drug candidates designed to efficiently block a well-established route of fibrosis.
We are driven by scientific innovation and committed to empowering patients and our employees. We recognize that our employees’ dedication and individual contributions are key to achieving our mission of bringing best-in-class inhibitors of fibrotic diseases to people in need. We offer a culture that encourages creativity and celebrates diverse backgrounds and viewpoints.
We are seeking passionate and compassionate individuals to join our team and to make a difference in the lives of patients.
Description
Reporting to the Sr. Director, Pharmacovigilance, the Sr. Manager, Pharmacovigilance, will contribute to a full range of PV activities including but not limited to pharmacovigilance organization and process development, review and tracking of safety reports and safety data, and inspection readiness activities. In addition, she/he will also function in a company matrix environment collaborating with several key groups including Clinical Operations, Biometrics and Data Management, Clinical Development, Regulatory Affairs, and Quality Assurance.
This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).
Responsibilities
- Ensure that all safety reports are triaged, scheduled, processed and reported accordingly per global requirements and applicable SOPs
- Communicate with partner companies, vendors, and internal group regarding processing and timely exchange of safety reports
- Perform and/or provide oversight for day-to-day interaction with PV vendor(s)
- Represent PV in study management teams or similar meetings for assigned products
- Develop or support development of standard operating procedures (SOPs) and/or other process related documents e.g. Safety Management Plans, Work Instructions
- Support organization and preparation for signal detection activities and Safety Review Committees or similar safety review meetings
- Conduct MedDRA and WHODrug coding and SAE reconciliation activities
- Participate in workflow development and strategic planning for the PV group
- Contribute to the development and review of clinical, regulatory, and scientific documents including protocols, Investigator Brochures (IBs), informed consent forms, clinical study reports, and/or other documents as needed
- Maintain knowledge of disease indications for assigned investigational and/or marketed products
- Develop templates, trackers, and other tools to aid in oversight and/or standardization of PV processes
- Review key performance indicators in support of pharmacovigilance quality and vendor oversight
- Support inspection readiness and compliance activities, including development of compliance reports and tracking of compliance metrics
- Organize and prepares materials in support of audits and inspections, and assist in identifying and follow-up of corrective actions arising from audits and/or inspections
- Assist in training development program for cross-functional personnel and external groups in pharmacovigilance principles and practices
- Contribute to writing and review of periodic safety reports, including DSURs and other periodic reports
- Present at Investigator Meetings, as directed
- Support organizational leadership in assigned activities and initiatives and actively participate in daily pharmacovigilance activities with a "can-do, hands-on, positive attitude"
- Other duties, as assigned
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
- Bachelor’s degree, preferably in scientific field, with a minimum 8 yrs experience or 4-6 yrs experience with an advanced degree (MS/PhD). Preferred, healthcare professional degree (RN/BSN, Pharm. D., M.D., or equivalent) with 2 years of clinical experience, or advanced degree in health sciences field.
- Greater than 5+ years of relevant pharmacovigilance experience in the biotechnology/pharmaceutical industry; other relevant experience may be considered
- Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EU, ICH guidelines and regulations pertaining to clinical development and post-marketing safety environments
- Working knowledge of industry standard safety databases (ARGUS and ARISg) and other electronic data capture systems
- Excellent knowledge of drug development process
- Knowledge of MedDRA dictionary with relevance to adverse event coding
- Knowledge of medical terminology and general principles of clinical assessment of AEs
- Experienced in supporting PV audits and/or health authority inspections
- Proficiency with Microsoft applications including Excel, PowerPoint, Word
- Able to set priorities, juggle multiple demands, and manage changing priorities.
- Able to think critically and be a proactive problem-solver.
- Able to work independently while exercising initiative, flexibility, and sound judgment.
- Excellent communication, interpersonal, and writing skills, including ability to work effectively cross-culturally and cross-functionally with internal and external stakeholders
- Ability to operate in alignment with Pliant’s values and culture.
The hourly rate for this role is $100.00/hr – $105.00/hr. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.
To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/.
What We Do
Pliant Therapeutics is a late-stage clinical company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases
We believe that by harnessing the therapeutic potential of integrin biology and TGF-β modulation, there is a potential to create drug candidates aimed at halting or even reversing fibrotic diseases and address the unmet needs of many patients.
Pliant’s co-founders include world-renowned researchers from the University of California, San Francisco (UCSF), who bring broad experience in fibrosis biology and small molecule chemistry. Together, the Pliant team is dedicated to translating scientific advances in fibrosis biology into novel therapies for patients in need.
