Sr Safety Specialist, Global Patient Safety (GLPS)

Foster City
See job description.
May 08 2021
Position Type
Full Time
Organization Type
Job Type

Sr Safety Specialist, Global Patient Safety (GLPS)
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

Essential Duties and Job Functions:
  • Performs or may lead activities relevant to post-marketing and clinical trial ICSR submissions, as well as aggregate reports and line listing submissions.
  • Reviews AE data from ICSR reports from both investigational and post-marketing products to ensure appropriate scheduling of submission records.
  • May assist with review of pharmacovigilance agreements and clinical trial safety reporting plans.
  • Interacts with other Pharmacovigilance functional areas for data quality issues impacting submission process.
  • Will liaise with Systems team for reporting rule management as needed.
  • Will liaise with clinical department, affiliate, distributors, or contract research organizations as needed on submission issues (i.e., obtaining clarification for submission issues).
  • Identifies issues/concerns in a timely and appropriate manner and provides possible solutions.
  • Meets specific data and quality targets for ICSR and/or aggregate report submissions.
  • Remains current with case management SOPs, guidance documents and database technology.
  • Organizes workload to ensure compliance with pharmacovigilance agreements and other global regulatory reporting requirements for ICSRs.
  • Demonstrates understanding of submission requirements for Gilead products.
  • Ensures departmental workflow processes and timelines are followed.
  • Serves as resource for global regulatory reporting requirements for Gilead sponsored clinical trials reports.
  • Organize training materials and train new employees in functional area.
  • Perform quality check of ICSR and aggregate submissions for junior staff members.
  • Acts as a trainer and mentor for more junior staff members.
  • May lead and manage functional projects or workstreams.
  • May serve as a point of contact to other functions in the organization or CRO's.
  • May have cross-functional exposure to ensure deadlines are met for specific projects.
  • 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.
  • May assist with analysis and evaluation of performance and development of ongoing training for the Submissions team.

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 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
  • Demontrates 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.
  • Case processing experience is required
  • Knowledge of clinical trials activities preferred
  • Ability to effectively represent PV Operations on multidisciplinary teams
  • Health care professional degree (i.e. RN, PharmD) and pharmacovigilance experience or clinical practice experience
  • Pharmacovigilance 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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