Drug Safety Physician
Astex Pharmaceuticals - Dublin, CA

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Work for a company that is making a difference in the fight against cancer. Astex Pharmaceuticals, Inc. www.astx.com , brings together high tech and biotech to discover and develop more effective medicines for the treatment of cancer. We are looking for a motivated, dedicated professional who wants to combine their skills with our uniquely talented team to change the current paradigm of drug discovery and development. This candidate will be working in the Corporate Office located in Dublin, California – just a 10 minute shuttle ride from the Dublin-Pleasanton BART station.

The position is based in the San Francisco Bay Area city of Dublin, California. Relocation assistance is available for this role. The appointee will be a MD who is board certified in internal medicine, with an active US medical license. Clinical experience in oncology or hematology will be a plus. A total clinical research experience of approximately 8+ years, with at least 4+ of years in a biopharmaceutical organization with the primary responsibility for Drug Safety and Pharmacovigilance. The position reports directly to the Chief Medical Officer.

Job Description:
Drug Safety Physician will contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for the Company’s investigational products. Will be responsible for on-going safety surveillance and signal detection/analysis and will manage and provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety. In addition, together with other physicians in Clinical Development, will monitor designated clinical trials and provide out of hours coverage. The candidate will also chair the company’s Executive Safety Advisory Committee (ESAC).

Job Responsibilities:
Manages Astex Safety Group

Medical and scientific Pharmacovigilance review of: Literature Reports including epidemiological background research; Clinical Trial Reports; Study Protocols; Investigator Brochures, Clinical Trial (Serious) Adverse Event Reports; Post-marketing ADR reports; Case files, narratives, coding, causality and expectedness assessment

Analysis of Adverse Event Reports during on-going surveillance and signal detection, including independent analysis of safety risks

Writing of safety section, including benefit risk assessment, of PSURs, Clinical Expert Statements and other documents as required; general PSUR support

Provide medical guidance to Safety Staff during the case processing cycle

Review and sign off technical documents written by Astex with respect to medically relevant matters with particular attention to those relating to drug safety

Chairs the company’s Executive Safety Advisory Committee (ESAC)

Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)

Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs)

Maintain up-to-date knowledge of projects by attending Professional Society Meetings

Provide medical safety expertise and training to other Astex personnel, as required

Maintain a current medical license

Keep current with professional and Pharmacovigilance regulations and knowledge

Monitor designated clinical studies and provide out of hours coverage together with other physicians in Clinical Development

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