Senior Safety Specialist
Senior Safety Specialist
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Health care professional degree (e.g., RN, PharmD) and 2+ years of drug safety experience or 1+ year of clinical practice experience
3+ years of drug safety experience and a BS degree in a life sciences field.
4+ years of experience in the drug safety field.
Essential Duties and Responsibilities:
- Independently establishes work priorities and direction with minimal input from Manager.
- Participate in Study Management Teams
- Responsible for PVE input in clinical trial activities (i.e., protocol & CRF reviews, data management plan reviews, CRO agreements & flows)
- Review, extract and accurately enter AE data from ICSR reports from both investigational and postmarketing products, if needed.
- 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.
- Have solid working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports
- Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate.
- Will interact with other Drug Safety functional areas to process adverse events efficiently and reliably.
- Will liaise with clinical department, affiliate, marketing or contract research organizations as needed on safety data issues (i.e., obtaining clarification or follow-up information).
- Identifies issues/concerns in a timely and appropriate manner and provides possible solutions.
- Meet specific data and quality targets for case handling
- Remain current with case handling SOPs, guidance documents and database technology
- Organizes workload to ensure compliance with SDEA and other global regulatory reporting requirements for ICSR.
- Demonstrates general understanding of appropriate labeling documents for Gilead products.
- Ensures departmental workflow processes and timelines are followed
- Works 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
- Oversee SAE reconciliations for multiple studies and set timelines for junior safety specialists.
- Identify cases requiring investigator letters and draft investigator letters independently
- Triage and assign the incoming reports.
- Perform quality check of ICSR for junior staff members
- Acts as a trainer and mentor for more junior staff members.
- Develop drug safety presentation for investigator meeting presentations.
- May lead and manage functional projects or workstreams (e.g. monitoring CRO activities).
- May serve as a point of contact to other functions in the organization or CROs.
- May have cross-functional exposure to ensure deadlines are met for specific projects.
- May develop and/or assist with providing aggregate data review of quality checks for the PV Operations team.
- May develop and/or assist with routine or ad-hoc reviews of processes or data entry conventions to ensure compliance with departmental SOPs and guidelines.
- May assist with review of non-reportable cases with minimal supervision from Manager.
- May participate in assigned projects such as inspection readiness activities or inspection interviews
- Excellent interpersonal and communication skills, both written and oral
- Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).
- Safety database and data entry experience preferred
- Understanding of medical terminology and the ability to summarize medical information required
- The ability to assess data and understand the medical/safety implications.
- Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
- 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 strict 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.
- Case processing experience is required
- Knowledge of clinical trials activities preferred
- Ability to effectively represent PV Operations on multidisciplinary teams
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 firstname.lastname@example.org for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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.
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