Gilead Sciences, Inc. Senior Safety Specialist, Pharmacovigilance & Epidemiology in Foster City, California

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Essential Duties and Job Functions:

  • Participates in Study Management Teams and responsible for Pharmacovigilance & Epidemiology (PVE) input and operational support in clinical trial activities (i.e., protocol & CRF reviews, clinical data management plan reviews, CRO agreements & SAE process flows)

  • Develop drug safety presentation for investigator meeting presentations

  • Training of CRO and investigators

  • May lead and manage functional projects or work streams (e.g. monitoring CRO activities)

  • Perform study unblinding and clinical trial reconciliation independently

  • Data review responsibility to ensure data entries made by Safety Coordinators are accurate

  • Interact with other PVE functional areas to process adverse events efficiently and reliably and liaise with clinical department, affiliate, marketing CRO's as needed on safety data issues

  • Review, extract and accurately enter AE data from ICSR reports from both investigational and postmarketing products

  • Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries

  • Review, enter, and verify follow-up information for cases and make accurate determination of significant information

  • Perform review of ancillary documentation accompanying ICSR reports and identifies pertinent information for incorporations into the case narrative

  • Correctly identify cases requiring targeted follow-up, determine relevant follow-up required and prepare follow-up queries

  • Meet specific data and quality targets for case handling and remain current with case handling SOPs, guidance documents and database technology

  • Organize workload to ensure compliance with SDEA and other global regulatory reporting requirements for ICSR

  • Demonstrate general understanding of appropriate labeling documents for Gilead products

  • Work with Submissions Team to properly identify global regulatory reporting requirements especially for Gilead sponsored clinical trials reports

  • Organize training materials and train new employees in functional area

  • Identify cases requiring investigator letters and draft investigator letters independently

  • Perform quality check of ICSR for junior staff members

  • May develop and/or assist with providing aggregate data review of quality checks for the PV Operations team and assist with review of non-reportable cases with minimal supervision from Manager

  • May particpate in assigned projects such as inspection readiness activities or inpection interviews and assist with peer review of cases

Qualifications:

  • Health care professional degree (i.e. RN, PharmD) and 2+ years of drug safety experience or 1+ year of clinical practice experience; Bachelors degree in a Life Sciences field with 3+ years of drug safety experience; or Associates degree with 4+ years of experience in the drug safety field

  • Proven effective interpersonal and communication skills, both written and oral

  • Demonstrated computer skills in Microsoft environment (Microsoft Excel, Power point and Word)

  • Case processing experience is required

  • Understanding of medical terminology and the ability to summarize medical information required

  • The ability to assess data and understand the medical/safety implications

  • Demonstrates initiative, teamwork and accountability

  • Demonstrated success working both independently and in collaboration with others

  • A quality driven individual with strong attention to detail and accuracy is required

  • Strong organizational skills, and ability to adapt to change

  • A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strick timelines is required

  • Ability to follow guidelines and procedural documents

  • Self-motivated and capable of working independently

  • Understands safety database structures and is familiar with data retrieval tools

  • Ability to effectively represent PV Operations on multidisciplinary teams

Preferred:

  • Safety database and data entry experience

  • Knowledge of clinical trials activities

  • Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. 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 careers@gilead.com for assistance.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead