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Manager, Drug Safety & Pharmacovigilance

Ultragenyx Pharmaceutical Inc.

Location:
Novato, CA
Posted Date:
7/8/2014
Position Type:
Full time
Job Code:
Mgr. Drug Safety/Pharmaco
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:
Drug Safety, Pharmacovigilance,

Job Description

Why Join Us

Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. We are launching five Phase 2 clinical trials and with another preclinical trial in the pipeline. Where possible, our strategy is to acquire and retain global commercialization rights to our products. Come join our team during this exciting time of growth. We are located in Novato, CA, 28 miles north of San Francisco.

The Manger, Drug Safety & Pharmacovigilance will report to the Director, Drug Safety, Clinical Development and be integral in developing standards and processes in the Drug Safety and Pharmacovigilance (DSPV) group. The incumbent will contribute to a full range of DSPV activities including operational activities and compliance. In addition, he /she will also function in a company matrix environment collaborating with several key groups including Biometrics, Clinical Development, Clinical Operations, Regulatory Affairs, and Quality Assurance.

Responsibilities
•   Ensure that all safety reports are triaged, scheduled, processed and reported accordingly per global requirements and Ultragenyx SOPs
•   Track cases to completion and adherence to processing timelines
•   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 DSPV vendor(s)
•   Represent DSPV in study management teams for assigned products
•   Development and implementation of Safety Management Plans for study specific SAE workflow between Ultragenyx and CRO(s)
•   Review Analysis of Similar Events for SUSARs
•   Oversee reconciliation of safety data with groups external to DSPV (e.g. data management, Business Partners)
•   Participate in workflow development and strategic planning for DSPV
•   Assist in development of new standard operating procedures and work guidance
•   Contribute to DSPV quality management plans and compliance program – assist in DSPV inspection readiness
•   Tracking of compliance metrics
•   Assist in identifying and following-up with on corrective action plans arising from audits and inspections
•   Assist in training development program for cross-functional personnel and external groups in drug safety principles and practices
•   May provide and prepare sections of relevant annual and/or periodic reports, as directed
•   Present at Investigator Meetings, as directed

Requirements

Requirements
•   Health care professional (RN, Pharm.D., MD, or equivalent) with, at minimum, 2 years of clinical experience, or Advanced degree in health sciences
•   5+ years of relevant Drug Safety / Pharmacovigilance experience in the biotechnology / pharmaceutical industry
•   Excellent knowledge of FDA, EU and ICH guidelines and regulations governing clinical trials and postmarketing safety
•   Proven ability to manage drug safety vendors
•   Knowledge of medical terminology and general principles of clinical assessment of AEs
•   Knowledge of MedDRA dictionary relevant to AE/SAE coding
•   Experience with software-based drug safety systems (ARGUS, ARISg, or equivalent)
•   Strong computer skills (MS Office)
•   Excellent communication and interpersonal skills, including ability to work effectively cross-culturally and cross-functionally
•   Excellent written and spoken English
•   Ability to listen and think critically (sometimes creatively)
•   Experience with public speaking, a plus
•   Experience with CROs and Business partners, a plus
•   EudraVigilance certified, a plus

EOE.

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