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Associate Director, Safety Physician

Gilead Sciences

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Location: Foster City, CA Posted Date: 4/8/2013 Position Type: Full time Job Code: Req 12360 Required Education: High school or equivalent Areas of Expertise Desired: Drug Safety

Description

Due to our continued growth, Gilead Sciences is seeking a primary care physician looking to transition into an industry role in drug safety. This position is based in Foster City, CA. Relocation assistance is available.

Gilead was founded in 1987 in Foster City, California. In 25 years, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents. Today, our research and development effort is the largest it has ever been, with more than 75 Phase 2 and 3 clinical studies evaluating compounds with the potential to become the next generation of innovative therapies for HIV, hepatitis, serious respiratory, cardiovascular and metabolic conditions, cancer and inflammation. In 2012, Gilead’s annual revenues reached approximately $9.7 billion, and in 2009, BusinessWeek ranked Gilead #1 in its annual listing of the 50 Best-Performing Companies.


Associate Director, Safety Physician


Specific Responsibilities:
Associate Director, Safety Physician, Medical Surveillance & Coding (MSC) within DSPH

* Reviews adverse event reports received for marketed and investigational products, and provides medical causality assessment. Responsible for the accuracy and completeness of case information, making corrections/additions as needed. Provides Analysis of Similar Events and medical comment for clinical trial IND safety letters
* Provides medical review and/or sign-off for clinical trial protocols, investigator brochures, clinical study reports, IND Annual Reports, and other documents for products in development, as part of a cross functional team
* Collaborates with drug safety’s pharmacovigilance scientists in the identification and assessment of safety signals and trends, and supports management of any potential safety issues; provides medical review of aggregate reports such as PSURs and other periodic safety reports.

Essential Duties and Job Functions:
* Complies with all regulatory requirements from competent authorities; maintains confidentiality; meets all safety reporting deadlines
* Works under consultative direction toward long-range goals and objectives, taking into account and providing support for the strategic goals of the organization; translates overall direction and strategy, communicates across organizational levels and functions; interprets and executes polices and procedures, and provides direction based on general policies and management guidance
* Participates in process improvement initiatives, identifies areas for improvement, and presents solutions
* Provides support and back-up for Director; provides medical judgment on complex safety topics; may provide medical safety support to the EU Qualified Person for Pharmacovigilance (QPPV)
* Participates in intradepartmental and interdepartmental cross-functional project teams; communicates across organizational levels and functions
* Provides support to the medical coding group on an ad hoc basis
* Participates in both internal and external educational initiatives; mentors junior staff to ensure competence in pharmacovigilance skills and knowledge
* Participates in literature review process on an ad hoc basis
* Provides medical review of SRDs for medical content and accuracy
* Participates in SOP updates, audits, data analysis, and other ad hoc activities
* Contributes to preparation and review of safety documents in response to regulatory inquiries
* Demonstrates strong proficiency in verbal and written communication
* Demonstrates excellent attention to detail, teamwork and initiative, with flexibility and ability to adapt to the needs of the organization; maintains meticulous attention to project deadlines.
* May recruit, hire, mentor and manage direct reports, with responsibility for employee performance evaluations
* May participate in budget planning and management.

Requirements

* Typically requires MD (UK: full GMC registration required) with demonstrated ability to handle the responsibilities, deliverables, and skills required for this level.
* Significant experience (7+ years) of clinical training (including 3 years of clinical residency) and clinical practice, drug safety/pharmaceutical industry, regulatory agency, or clinical research is preferred

This is an ideal role for a primary care physician looking to transition into an industry role in drug safety.

Interested applicants should apply to: http://www.gilead.com/careers_foster_city

Req 12360
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