Associate Manager, Risk Management, MSC, DSPH 9/10/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONAPPLY SPECIFIC RESPONSIBILITIES
Responsible for the following activities as appropriate, with close supervision:
- Signal detection and authorship of signal work-up documents in collaboration with a safety physician
- Authorship of CCDS sections and associated supporting documentation
- Authorship of aggregate safety reports (e.g., PSURs)
- Authorship of risk management plans
- Authorship of responses to regulatory agency safety enquiries
- Contribution to safety analyses in Regulatory submissions (e.g., MAAs, NDAs)
- Reviews global literature for identification of individual case safety reports and potential safety concerns
- Safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies.
- Understands core safety information versus local labelling and reviews standard reference documents and develops listedness/expectedness tables in collaboration with a safety physician
ESSENTIAL DUTIES AND JOB FUNCTIONS
Familiar with searching drug safety and literature databases for relevant information
Develops contacts within DSPH and across the company and use those contacts to manage projects more effectively
Communicates effectively with functional peers and others within DSPH to ensure relevant parties are fully informed and knowledgeable of project activities and their status
Contributes to safety committee meetings (internal or with partner companies)
Participates as a member of various cross-functional teams, including participation on Clinical Development Teams involving interaction with Medical Monitors, Clinical Scientists, Clinical Operations, and other Medical Affairs personnel
May act as a mentor to employees with less experience
May lead projects with supervision
KNOWLEDGE, EXPERIENCE AND SKILLS
Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline.
Some experience (2+ years) in the pharmaceutical industry, at a regulatory agency, or in clinical research is preferred.
Demonstrates a good level of competency in verbal and email communication, including Microsoft Excel, Word, and Power Point
Demonstrates good attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
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