Manager, Drug Safety and Pharmacovigilance - Novato, CA | Biospace
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Manager, Drug Safety and Pharmacovigilance

Ultragenyx Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
7/10/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Other
Areas of Expertise Desired:
Drug Safety, Manager, 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. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.  

Come join our team during this exciting time of growth and opportunities!

We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco

Position Summary:

This position is integral for the safety assessment of products throughout their lifecycle and management of global drug safety processes in conjunction with the Company’s overall objectives. The DSPV Manager will be responsible for developing standards and processes with an emphasis on global compliance and maintaining the PSMF. This individual must effectively interface cross-functionally at all levels in the organization as well as externally with vendors and regulatory authorities. He or she may have post-marketing product level responsibilities, and will need to work together with the Safety Director to manage the safety assessment of products, that may include review of individual and aggregate AEs and the scientific literature, prepare safety reports and communicate changes in the product risk profile to internal and external stakeholders.  The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Responsibilities, including but not limited to:
•   Co-ordinate and oversee collection and incorporation of the information to the PSMF.
•   Ensure inspection readiness of the PSMF
•   Assist head of Pharmacovigilance to analyze content of the PSMF and log books to identify non-compliance and share feedback with relevant functions
•   Inform QPPV about non-compliance with provision of the information to the PSMF or poor quality of such information.
•   Maintain awareness of processes and any arising Safety issues to be able to provide additional level of back up to the Head of Pharmacovigilance, QPPV and deputy QPPV
•   Ensure that all safety reports, both post-marketed and clinical trial, are triaged, scheduled, processed and reported accordingly per global requirements and Ultragenyx SOPs
•   Process post-marketing cases and track cases to completion and adherence with processing timelines
•   Communicate with partner companies, vendors, and internal groups regarding processing and timely exchange of safety reports
•   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 and 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
•   Provide oversight for day-to-day interaction with DSPV vendor(s)
•   Oversee reconciliation of safety data with groups external to DSPV (e.g. call center, data management, Business Partners), if required
•   May provide and prepare sections of relevant annual and/or periodic reports, as directed

Requirements


•   Health care professional (RN, PharmD, or equivalent) with, at minimum, 2 years of clinical or research experience;   training in genetics, pediatrics, pharmacology, epidemiology or regulatory science is a plus.
•   3+ years of relevant Drug Safety / Pharmacovigilance experience in the biotechnology / pharmaceutical industry with experience in both the pre-marketing and post-marketing pharmacovigilance
•   Experience with maintaining a PSMF
•   EudraVigilance certified is a plus
•   Excellent knowledge of FDA, EU and ICH guidelines and regulations governing clinical trials and postmarketing safety
•   Able to oversee and 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)

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.