Atara Biotherapeutics, Inc.

  • Manager/Senior Manager - Drug Safety & Pharmacovigilance

    Job Locations US-CA
    ID
    2019-1071
    Category
    R&D Admin
    Type
    Regular Full-Time
  • Overview

    The Manager/Senior Manager Drug Safety & Pharmacovigilance will be involved with global pre- and post-marketing drug safety and pharmacovigilance activities and will be responsible for assuring the processing and reporting of safety reports in compliance with SOP’s, guidelines and worldwide pharmacovigilance regulations. This position must effectively interface cross-functionally at all levels in the organization, as well as externally with vendors and corporate partners.

    Responsibilities

    We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.


    Position Summary:

    The Manager/Senior Manager Drug Safety & Pharmacovigilance will be involved with global pre- and post-marketing drug safety and pharmacovigilance activities and will be responsible for assuring the processing and reporting of safety reports in compliance with SOP’s, guidelines and worldwide pharmacovigilance regulations. This position must effectively interface cross-functionally at all levels in the organization, as well as externally with vendors and corporate partners.

    Reports to:  Director, Drug Safety & Pharmacovigilance

    Location:  Thousand Oaks, CA (Northwest Los Angeles)

    Primary Responsibilities:

    • Oversight of contracted safety providers by ensuring safety functions and deliverables are of high quality in alignment with Master Service Agreement and applicable Statement of Work.
    • Ensures the uniform and timely processing of safety reports in accordance with SOPs.
    • Performs standard quality check of data entry of adverse event reports or other safety documents.
    • Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events.
    • Oversees and/or performs safety activities associated with case management such as SAE reconciliations, vendor reconciliations, submission compliance, and case QC, and case closure activities.
    • Oversight of safety activities involving corporate partners to ensure compliance with contracts and agreements related to safety case processing and reporting.
    • Performs root cause analysis and investigation of issues related to case processing/safety operations.
    • Initiates corrective and preventive action (CAPA) measures following review of root cause analysis.
    • Subject Matter Expert in the development and maintenance of PV plans including safety management plans, regulatory reporting plans, and SAE reconciliation.
    • Leads and/or maintains safety department project management activities (e.g. organize safety team meetings, maintain safety project timelines, take meeting minutes, archive safety-related documents, etc).
    • Supports the planning and preparation of aggregate safety reports such as the Development Safety Update Report, Periodic Benefit Risk Evaluation Report, periodic line listings, ad-hoc analyses, etc. as assigned.
    • Supports signal detection and risk management activities.
    • Provides safety representation in study team key activities such as SAE reconciliation.
    • Maintains departmental and pharmacovigilance documentation in an audit-ready state.
    • Participates in inspections and audits including inspection readiness activities
    • Supports Drug Safety & Pharmacovigilance department initiatives on ad hoc basis.
    • Assists in creation of PV related training materials, authoring of PV SOPs and work instructions.
    • Reviews MedDRA/WHO Drug coding as requested.
    • Other responsibilities as assigned.

    Skills and Abilities:

    • Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.
    • Knowledge of MedDRA dictionary relevant to AE/SAE coding
    • Experience with software-based drug safety systems (ARGUS experience is required)
    • Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
    • Detail-oriented, with good organizational, prioritization, and time management proficiencies.
    • Must be able to work on multiple projects simultaneously.
    • Ability to prioritize work without much support.
    • Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
    • Proficient in standard computer software (Word, Excel and Power Point)

    Qualifications

    Education and Professional Experience:

    • A minimum 5+ years of pharmacovigilance experience at a biotech, pharmaceutical, or CRO company, with at least 4 years hands on experience in adverse event case management is required.
    • Safety case processing experience is required.
    • Bachelor’s degree required in a health care discipline (RN, PharmD, PA is preferred)
    • Job title based on experience.

    Physical Requirements:  Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment.

    Travel: Some travel may be required (<10%)

     

     

    More About Atara Bio:
    Now in our sixth year, we’re proud of our team of 300+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.

    One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”

    The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.

    Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).

    Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).

    Working at Atara Bio:
    People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.

    Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.

    We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States. 

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