Senior Safety Specialist, GLPS Operations (Clinical Trial Support)
Senior Safety Specialist, GLPS Operations (Clinical Trial Support)
Ireland - Dublin
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
The way we see it, the impossible is not impossible. It's simply what hasn't been achieved yet.
Creating Possible drives everything we do. It's evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving lives of people around the world.
At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where employees band together through science, grit, compassion and courage to prove the impossible wrong.
We have an opportunity for a Senior Safety Specialist working within the Global Patient Safety (GLPS) team. The role will involve case processing activities and also participation in Study Management Teams and be responsible for GLPS input and operational support in clinical trial activities (i.e., protocol & CRF reviews, clinical data management plan reviews, CRO agreements & SAE process flows).
Essential Duties and Job Functions:
- Sets work priorities and direction with input from Manager.
- 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.
- Performs 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 GLPS 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.
- 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.
- May assist manager in the preparation of training material and assist in training new employees.
- May assist with other projects as necessary (i.e, study unblinding).
- Perform clinical trial reconciliation with minimal supervision from Manager or Sr Safety Specialist.
- Identify cases requiring investigator letters and draft investigator letters with minimal supervision from Manager or Sr Safety Specialist.
- May triage and assign the incoming reports.
- Acts as a trainer and mentor for more junior staff members.
- Participate in some clinical trial activities with supervision from Manager or Sr Safety Specialist (i.e., protocol & CRF reviews, clinical data management plan reviews, CRO agreements & SAE process flows, SAE reconciliation).
- May participate in Study Management Teams (as applicable).
- May assists in the development of safety presentation for investigator meeting presentations.
- May assist with peer review of cases.
- May assist with analysis and evaluation of performance and development of ongoing training for Operations group.
Knowledge, Experience and Skills:
- 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 is preferred
- 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 preferred
- Knowledge of clinical trials activities preferred
- Healthcare professional degree (i.e., RN, PharmD) with a good level of safety experience or industry experience OR A good level of safety experience and a BS degree in a life sciences field
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
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