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Senior Manager, France Affiliate Patient Safety
il y a 2 semaines
For Current Gilead Employees and Contractors:
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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**:
The Gilead Sciences, France Affiliate Patient Safety Senior Manager provides support to the Affiliate Head of Patient Safety (AHoPS) and global team to ensure strong engagement within the business ensuring engagement and integration within the affiliate. This position is involved in many aspects of pharmacovigilance coordination and execution at the affiliate and will provide back-up support to the AHoPS as required.
The France Affiliate Patient Safety Senior Manager performs the role of AHoPS back up/ local nominated Pharmacovigilance responsible person for France back up in accordance with local legislative requirements.
Key Responsibilities
Strategic PV partner
Patient Centricity: Responsible for bringing local insights to the decision-making process and into local benefit / risk and risk management development.
Local projects: Partner with Program Owners and commercial leaders to implement pro-active, efficient, and compliant solutions for the management of safety activities. Ensuring that relevant business partnerships have considered the impact to safety. e.g., awareness and input into new product launches and oversight of local solicited programs (Patient Support Programs, Market Research, Digital Media), providing support and review of contracts to ensure alignment with global standards. Partners to the global Patient Safety Solicited Program and Clinical Trial teams.
Local study strategic insights: Provide strategic input into local post marketing surveillance studies (PMS), local post approval safety studies, local sponsored studies, Investigator Sponsored Research (ISRs) and local early Access Programs called “Accès Précoce” and “Accès compassionnel”
Local Subject Matter Expert (SME) for product safety: Provide expertise on product safety knowledge and Patient Safety position on safety matters
Local Safety Contact Point
Point of contact within the Affiliate for safety related enquiries.
Audits and Inspections: Responsible for both internal PV audits and Regulatory Agency PV inspections in collaboration with Chief Pharmaceutical Officer (CPO) and local affiliates teams and global Patient Safety team.
Risk Management: Responsible for ensuring the appropriate development and revision of local RMPs and/or Country Specific Annexes in collaboration with global Patient Safety team and local Regulatory as required. Provide oversight & leadership of local risk minimization activities and materials as applicable.
Regulatory Intelligence & Industry Forums: Actively contribute to local industry forums, meetings, and seminars.
- Maintain expert knowledge of local pharmacovigilance regulations.
- Provide interpretation and communicate impact of changes in local pharmacovigilance regulatory requirements to global Patient Safety team
- Feedback and influence local legislation consultations as appropriate
Communication of Safety Information: Provide leadership and local decision making in collaboration with global Patient Safety on communication of Safety Information to CPO and external & internal stakeholders, e.g.:
- Submit or delegates submission of relevant information to the authorities as required locally via collaboration with Regulatory and global Patient Safety. To include but not limited to; PSUR, signals, RMP, PMS & responses to Health Authority inquiries.
Communicate safety related issues and information that may be of relevance to the identification of potential safety signals to CPO, Patient Safety Therapeutic Area (TA) leads / qualified person responsible for pharmacovigilance in the European Union (EU QPPV) and local stakeholders.
Pro-active PV forecasting
Integration into Business: Act as the Patient Safety ambassador delive
