Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases around the world.

Our portfolio of 14 marketed products includes a number of category firsts, including the only complete treatment regimens for HIV infection available in a once-dailysingle pill — Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), approved in 2006, and Complera™, approved in 2011.

Safety Physician, Medical Surveillance and Coding

Specific Responsibilities
* Reviews adverse event reports received for marketed and investigational products, and provides medical assessment (focused on causality with regard to Gilead product).
* 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 risk management team 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
* Works under consultative direction toward long-range goals and objectives, taking into account and providing support for the strategic goals of the organization; participates in process improvement initiatives, identifies areas for improvement, and presents solutions; works with almost no direct supervision.
* 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.
* Complies with all regulatory requirements from competent authorities; maintains confidentiality; meets all deadlines.
* Provides support to the medical coding group on an ad hoc basis.
* Participates in both internal and external educational initiatives; may be involved in mentoring junior staff.
* May participate in literature review process on an ad hoc basis.
* May provide medical review of Standard Response Documents for medical content and accuracy.
* May participate in SOP updates, audits, data analysis, and other ad hoc activities.

Knowledge, Experience, and Skills
* MD required; US medical board certification/equivalent preferred
* Previous direct patient care experience with strong knowledge of clinical medicine required; industry experience, especially in drug safety, is a plus
* Strong analytical skills, with ability to assess data and understand the safety and medical implications
* Strong verbal and written communication skills in English
* Candidate must be a team player; detail oriented; flexible, with the ability to adapt to the needs of the department/organization

Specific Education & Experience:
* At least 4 years experience in a clinical setting.

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

To apply for the position, please click here.

Gilead is an equal opportunity employer.

• Location: Bay Area, California
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