Sr Safety Pharmacovigilance & EPI H/F
Sr Safety Pharmacovigilance & EPI H/F
France - Paris
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, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
We are looking for a Manager / Global Patient Safety (GLPS) H/F to join the French team in a fix term contract (7 months).
The role is office based (Boulogne-Billancourt, 92).
Essential duties and responsibilities include, but are not limited to the following:
Ensuring that local pharmacovigilance activities are conducted such that the Affiliate(s) is in compliance with regulatory and internal company standards as set out within applicable regulations or guidance and global or local Procedural Documents (PDs).
Managing all aspects of local Individual Case Safety Report (ICSR) Management:
- 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 on a weekly basis or according to journal publications.
- 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.
Overseeing the local Quality Management System:
- Training Affiliate(s) staff on safety reporting procedures including the timely reporting of safety information to GLPS / Pharmacovigilance Responsible Person (PRP) 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.
- Performing applicable quality checks of local cases before routing, Regulatory Authority submissions and review of medical information enquiries.
- Ensuring archiving of safety data in accordance with the Gilead's retention policy and national requirements.
Maintaining local knowledge in relation to:
- 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.
Serving as the point of contact within the Affiliate:
- 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.
Utilising and proactively participating in the PRP Network and accessing available GLPS resources:
- 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 PRP network video or teleconferences and an annual PRP face to face meeting where possible, and actively participates in PRP meetings to share best practices.
KEY ROLE-RELATED COMPETENCIES / EDUCATION and/or EXPERIENCE REQUIRED
- Confirmed practical experience in pharmacovigilance
- Ability to work with a high degree of autonomy
- Comprehensive understanding of drug safety regulations and obligations
- Proven leadership or influencing skills
- Ability to represent Gilead externally
- Excellent communication skills
- Very good written and spoken English
Gilead Core Values
- Integrity (Doing What's Right)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
- Inclusion (Encouraging Diversity).
For jobs in France:
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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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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/France---Paris/Manager-Pharmacovigilance-H-F_R0016762-2
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