Drug Safety Physician - South San Francisco, CA | Biospace
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Drug Safety Physician

Portola Pharmaceuticals, Inc.

Location:
South San Francisco, CA
Posted Date:
8/18/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:
Drug Safety, MD,

Job Description


Portola Pharmaceuticals is a biopharmaceutical company, headquarted in South San Francisco. Developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s first medicine Bevyxxa® (betrixaban), an oral, once-daily Factor Xa inhibitor, was approved by the U.S. Food and Drug Administration in June 2017. The company is also working to advance two clinical programs for AndexXa® (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a SYK/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective SYK inhibitors for inflammatory conditions. These wholly owned compounds come from our own internal research efforts and represent important advances to address significant unmet needs.

Position Summary:  

The Portola Clinical Development Department seeks a Drug Safety Physician in support of three clinical stage development programs. The Safety Physician is responsible for the Clinical Safety strategy for Portola’s assigned drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level. This position reports to the Senior Director, Drug Safety/Pharmacovigilance and is located in South San Francisco.

Responsibilities:

•   Leads the established safety data review process, including review of Individual Case Study Reports and aggregate data
•   Responsible for signal detection and analysis, providing a proactive safety analysis plan for risk assessment including monitoring adverse event reports, trends and frequencies, and assessment of various datasets
•   Provides medical input to regulatory supporting documentation for labeling updates
•   Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals
•   Collaborates with external provider representatives in routine signal management activities
•   Discusses the results of data evaluation with the Surveillance Team and/or appropriate key stakeholders, Provides medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data
•   Provides strategic input into responses to regulatory requests for local label deviations from the company core safety documentation
•   In consultation with the Sr. Director DS and Clinical representatives, prepares the Developmental Core Safety Information (DCSI) for assigned development products

Requirements


Requirements:

•   Medical degree required (MD)
•   Minimum 2 years of Drug Development/Patient Safety experience
•   Minimum 2 years of clinical experience post-registration
•   Thorough working knowledge of US and EU clinical research and global safety requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities
•   Acts Decisively (create clarity for others to act decisively)
•   Drives Accountability (creates cross-boundary accountability)
•   Works Collaboratively (establishes shared purpose across boundaries)
•   Good organizational and prioritization skills
•   Working knowledge of MedDRA and WhoDrug
•   Ability to work under pressure and provide quality outputs within tight timelines
•   Excellent communication and presentation skills