Medical Director, Drug Safety & Pharmacovigilance
Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: May 3, 2021
The Medical Director, Drug Safety & Pharmacovigilance provides
hands-on and strategic input for PV activities associated with
investigational and commercial stage products. This individual has
a highly visible role across all levels of management and
Reports to Senior Medical Director, Drug Safety & PV
Location West Coast, preferably Thousand Oaks (northwest Los
Angeles area) or San Francisco Bay Area, CA
Travel Up to 20%
- 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.
- Medical Review of AEs
- Medical review of ICSRs.
- 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
- 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 departments, EU
QPPV, clinical sites, vendors and partners.
- Prepares for regulatory inspections and audits and develops
corrective action plans when needed.
- Prepares training material / Presentations for internal and
external safety presentations (e.g. investigators meetings, SIVs,
independent data monitoring committees...).
- Medical doctorate degree preferred.
- 5+ 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
- Excellent interpersonal skills, ability to develop important
relationships with key stakeholders, ability to analyze complex
issues and develop relevant and realistic plans, programs and
- 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
- Strong understanding of pharmacovigilance regulations and
international regulations governing drug safety (US and EU) for pre
- Demonstrated leadership and collaborative skills necessary to
influence across functions and earn credibility across a complex
and rapidly growing organization.
- Role model for Atara TRAIT values (Transparency, Respect,
Accountability, Integrity, Trust).
More about Atara Bio
We launched Atara Biotherapeutics in August 2012 to help
patients with serious diseases and few therapeutic options. 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 425+ Atarians co-located by design in
4 different locations including South San Francisco (corporate
headquarters), Thousand Oaks (R&D and manufacturing
headquarters), Zug, Switzerland (european headquarters) and a
R&D site in the Denver, Colorado area. 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. Our mission -
"Transform the lives of patients with serious medical conditions
through pioneering science, teamwork, and a commitment to
Our vision - "T-Cell Immunotherapy for every patient, any
Atara offers a competitive benefits packages that includes
medical/dental/vision benefits, life and disability, retirement and
stock program, as well as a generous paid time off and wellness
plan that supports the well-being of our staff. Visit
www.atarabio.com/careers 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.
Keywords: Atara Biotherapeutics, Thousand Oaks , Medical Director, Drug Safety & Pharmacovigilance, Other , Thousand Oaks, California
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