Manager, Risk Management, MSC, DSPH
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POST DATE 8/30/2016
END DATE 10/26/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
Manager, Risk Management, Medical Surveillance & Coding (MSC) within DSPH.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Responsible for the following activities as appropriate, with minimal 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 s brochures, study reports, informed consent forms, and other study related documents for assigned studies
- Reviews standard reference documents and develops listedness/expectedness tables in collaboration with a safety physician
Collaborates with partner companies on safety evaluation for co-licensed products with minimal supervision
Makes significant contributions to safety committee meeting discussions (internal or with partner companies)
Participates on and may lead various cross-functional teams involving interaction with Gilead staff within and external to DSPH.
Leads multiple projects simultaneously with minimal supervision
May write drug safety SOPs and contribute to drug safety audits or inspections
May manage direct reports with responsibility for employee performance evaluations
Acts as a mentor to junior employees
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 with demonstrated experience with the responsibilities, deliverables, and skills required for this level.
Moderate level (4+ years) of experience in drug safety is preferred.
Demonstrates proficiency in verbal and email communication, including Microsoft Excel, Word, and Power Point
Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines
Successful track record of developing contacts within DSPH and across the company and using 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
Demonstrated ability to work effectively with safety physicians, other members of DSPH, and colleagues external to DSPH.
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