Job Locations US-CA-Thousand Oaks
Title
Director, Drug Safety & Pharmacovigilance
ID
2020-1313
Category
Safety
Type
Regular Full-Time

Job Description

The Director, Drug Safety & Pharmacovigilance provides hands-on and strategic input for PV activities associated with investigational and commercial stage products. This individual helps build the Safety Department and has a highly visible role across all levels of management and functional areas.

 

Reports to        Vice President, Safety

Location          Thousand Oaks (northwest Los Angeles area), CA

Travel              Up to 20%

 

Primary Responsibilities

  • Medical safety expert for products.
  • Signal detection, signal investigation and assessment, literature review, proactive management of the benefit-risk profile for assigned products and any resultant activities such as revisions to core safety information.
  • Risk management activities, including risk strategies for assets in all phases of development and life-cycle.
  • Routine PV activities of assigned programs including medical review, analysis of similar events, and literature review.
  • Coding reviews and reconciliation activities in collaboration with Data Management.
  • Coordination and project management of aggregate safety reports (e.g. PSURs/PBRERs, PADERs).
  • Contribution to safety sections of key documents (e.g. protocols, ICFs, IBs, RMPs, CDS, labels, INDs).
  • Contribution to regulatory submission documents, response to queries and other regulatory enquiries.
  • Performs aggregate analyses of specific events across studies, prepares and presents safety analyses at the Safety Committees, and writes Safety Assessment Reports.
  • Interacts with contract vendors (case processing, call center, etc.) to resolve safety-related issues.
  • Contributes to Post Authorization Safety Studies (PASS) and safety registries.
  • Reviews Safety Data Exchange Agreements as applicable.
  • Supports the safety department in organizing post-marketing activities in all applicable regions.
  • Contributes to and reviews SOPs.
  • Serves as a PV Safety contact to other Atara’s departments, EU QPPV, clinical sites, vendors and partners.
  • Prepares for regulatory inspections and audits and develops corrective action plans when needed.
  • Prepares training material for internal and external safety presentations (e.g. investigators meetings, SIVs).
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Qualifications

Position Requirements

  • PhD or Medical doctorate degree required.
  • 7 or more years of pharmaceutical experience. Immuno-oncology and neurology are preferred.
  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, ability to analyze complex issues and develop relevant and realistic plans, programs and recommendations.
  • Effective communication is a key aspect as this role involves close collaboration with colleagues from other functions such as Clinical Sciences, Clinical Operations, Regulatory Affairs, Translational Medicine, Data Management, Quality Assurance, Medical Affairs, Commercial, and Legal.
  • Excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
  • Deep clinical knowledge, with medical practice experience.
  • Excellent ability to communicate, specifically on medical and scientific topics.
  • Strong understanding of pharmacovigilance regulations and international regulations governing drug safety (US and EU) for pre and post-marketing.
  • Demonstrated leadership and collaborative skills necessary to influence across functions and earn credibility across a complex and rapidly growing organization.
  • Role model for Atara’s Values of patients first, innovation teamwork, community and mindset.

More about Atara Bio

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.

 

We’re proud of our team of 350+ 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.

Our mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence.”

 

Our vision - “T-Cell Immunotherapy for every patient, any time.”

 

Visit www.atarabio.com to learn more.

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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