Head of Patient Safety, Benelux
Netherlands - Amsterdam
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
Gilead Sciences is seeking an ambitious individual to be the Head of Patient Safety Benelux to be responsible for safety activities in Benelux. This role is a local role, however, is part of Gilead's global Global Patient Safety (GLPS) function. This is a broad and all-encompassing, independent role that will undertake the management and conduct of all Pharmacovigilance activities; ensuring that local pharmacovigilance activities are conducted in compliance with regulatory and internal company standards as set out within applicable regulations or guidance and global or local Procedural Documents (PDs).
The ideal candidate will possess:
- Scientific background along with a medico-scientific university degree e.g. Life Science
- Pharmaceutical research / drug safety experience in both clinical and post-marketing environment
- Comprehensive knowledge of global safety regulatory requirements and extensive knowledge of safety regulations pertaining to Benelux
- Working knowledge of European GVP and Regulations pertaining to Adverse Event Reporting
- Effective communicator (written and oral); concise, accurate and business appropriate
- Proven ability to work cross functionally
- Teamwork and initiative
- Excellent attention to detail and be able to demonstrate and deliver high quality work
- Ability to maintain confidentiality (especially on patients' records), quality and accuracy
- Good communication skills
- Good written and spoken English and Dutch is required; knowledge of the French language is desired
Specifically, the Head of Patient Safety in Benelux is responsible for: Overseeing the local PV Quality Management System:
Maintaining local knowledge in relation to:
- Ensuring availability of current organisation charts, job descriptions, Curriculum Vitae and training records for safety personnel in the Affiliate(s).
- Training Affiliate(s) staff on safety reporting procedures including the timely reporting of safety information to GLPS e.g. new hire training, sales and solicited programs training and ensuring all training is documented.
- Maintaining knowledge of global PDs as they pertain to Affiliate(s) and ensures that local PDs, including a Business Continuity Plan (BCP) are in place for specific local processes that are not covered by a global PD.
- Ensuring an after-hours process is in place locally for the receipt of safety requests and that the system is tested at least annually and that the test is documented.
- Reviewing the monthly global compliance reports produced by GLPS and taking necessary corrective actions locally as applicable.
- Performing applicable quality checks of local cases before routing, Regulatory Authority submissions if applicable and review of medical information enquiries.
- Ensuring archiving of safety data in accordance with the Gilead's retention policy and national requirements.
Serving as the point of contact within the Affiliate:
- the Gilead Pharmacovigilance organization.
- local Regulatory Authority contacts and local Pharmacovigilance regulatory requirements (and communicating changes in requirements to GLPS), specifically for submission of safety reports including PBRER/PSURs and creation of local Pharmacovigilance plans.
- studies and solicited programmes on going in their region.
- marketed status of Gilead products in the local country(ies).
- local licensing agreements (if applicable).
- safety related issues and forwarding any information that may be of relevance to the identification of potential safety signals to GLPS / EU QPPV and local senior management.
- for safety related enquiries and serving as the local Qualified Person for Pharmacovigilance (QPPV)/person notified to local Regulatory Agencies as needed.
Managing all aspects of local Individual Case Safety Report (ICSR) Management:
- for local Regulatory Authority inspections relating to Pharmacovigilance.
- for interfaces between local affiliate staff e.g. for local solicited programmes, advice, support and review of contracts as necessary to ensure alignment with global standards.
- where required by local law may act as contact point for communication with the local Regulatory Agency on safety submissions such as PBRERs/PSURs, Risk Management Plans and Risk Minimisation Activities and other safety matters.
- Performing the role of the owner of the local Pharmacovigilance department and responsibility for associated local procedures.
Utilising and proactively participating in the Network and accessing available GLPS resources:
- Collecting, recording, processing, translating and submitting AEs and special situation reports (SSRs) from all sources to GLPS (including reports from local literature, websites and solicited programmes) in compliance with corporate requirements and local regulations.
- Conducting appropriate and timely follow-up on all ICSRs, including use of targeted questionnaires.
- Screening of local literature (where not covered in the global search) for Adverse Drug Reactions, SSRs or other relevant safety data.
- Recording and maintaining ICSR data (including the management of follow-up) in the Local Affiliate Module of the global safety database (LAM).
- Ensuring that appropriate ICSRs are notified to the local Regulatory Authority in a timely manner and in accordance with corporate and regulatory requirements where applicable and recorded in LAM.
- Utilises GLPS systems and resources such as the Agreement Repository, Drug Safety Shared drive and the GLPS webpage to ensure access to up to date information including global PV Agreements, PBRERs/PSURs, RMPs and the Pharmacovigilance System Master File.
- Attends quarterly network video or teleconferences and an annual face to face meeting where possible, and actively participates in meetings to share best practices.
The ideal candidate will also be able to display engagement and commitment to the Gilead Core Values, which are:
Equal Employment Opportunity (EEO)
- Teamwork - Working together
- Excellence - Being your best
- Accountability - Taking personal responsibility
- Integrity - Doing what's right
- Inclusion - Encouraging Diversity
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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