Senior Safety Specialist, PV Operations (Vendor Oversight)
Senior Safety Specialist, PV Operations (Vendor Oversight)
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 Responsibilities:
- Assists vendors in resolving case processing questions, reviews and provides feedback on cases in question ensuring compliance with Gilead procedural documents and global regulations.
- Supports the oversight of quality control (QC), checks for data entered for ICSR reports from both investigational and postmarketing products to ensure accuracy and compliance with Gilead conventions and regulatory standards.
- Supports production of periodic QC reports in order to identify trends and propose and implement corrective actions.
- Supports oversight of vendor quality and provides feedback to the Ops vendor management team.
- Monitors and triages incoming queries from the vendors, prioritizing and providing a response in a timely manner.
- Performs retrospective QC checks as required.
- Provides input into GLPS SOPs, WRKs and manuals as required.
- Seeks assistance from appropriate internal and external resources.
- Will interact with other GLPS functional areas with respect to QC and Vendor Oversight (VO) activities.
- Identifies issues/concerns in a timely and appropriate manner and provide possible solutions.
- Escalates issues as needed to Vendor Oversight Management and/or Quality Management.
- Communicates functional area updates to vendors.
- Remains current with case handling SOPs, WRKs, manuals and database technology.
- Ensures departmental workflow processes and timelines are followed.
- Acts as a trainer and mentor for more junior staff members.
- Develop, present and maintain training materials to support vendor activities.
- Develops and/or assists with routine or ad-hoc reviews of processes or data entry conventions to ensure compliance with departmental SOPs and guidelines.
- May represent case processing function at operational meetings.
- Supports the oversight of specific activities or responsibilities that are delegated to junior staff members to ensure quality and accuracy of deliverables, and that timelines are met appropriately.
- Processes Individual Case Safety Reports (ICSRs) on an as needed basis.
- May participate in assigned projects such as inspection readiness activities or inspection interviews.
COMPANY CORE VALUES
- Teamwork - Working together
- Excellence - Being your best
- Accountability - Taking personal responsibility
- Integrity - Doing what's right
- Inclusion - Encouraging diversity
CORE COMPETENCIES FOR GLOBAL PATIENT SAFETY
- Excellent interpersonal and communication skills, both written and oral.
- Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).
- Safety database, data entry and QC experience preferred.
- 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 strict timelines is required.
- Ability to follow guidelines and procedural documents.
- Self-motivated and capable of working independently.
- Understanding of medical terminology and the ability to summarize medical information required.
- Ability to assess data and understand the medical/safety implications.
- Understands safety database structures and is familiar with data retrieval tools.
QUALIFICATIONS AND EXPERIENCE
- Healthcare professional degree (i.e. RN, PharmD) and drug safety experience or clinical practice experience.
- Drug safety experience and a BS degree in a life sciences field or a good level of experience in the drug safety 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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