Patient Safety Manager

hace 4 semanas

Ciudad de México Gilead Sciences A tiempo completo

For Current Gilead Employees and Contractors:
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 Mexico Affiliate Manager, Patient Safety, 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.

Gilead is seeking an ambitious and experienced individual to support the AHoPS to perform pharmacovigilance activities. This local role is based in Mexico and is part of Gilead’s global Patient Safety function.

This is a broad role that will be involved in many aspects of pharmacovigilance coordination and execution at the affiliates. Will provide back up support to the AHoPS as required ensuring that local PV activities are conducted in compliance with applicable regulations and guidelines and internal company procedural documents.

Patient Safety staff are strategic partners with local and global teams ensuring the patient is at the forefront of decision making and that the highest patient safety standards are met.
- Scientific background.
- Drug safety experience in the post-marketing environment.
- Comprehensive knowledge of global safety regulatory requirements and extensive knowledge of safety regulations and Good Pharmacovigilance Practices.
- Knowledge of local healthcare systems to enable input into local benefit / risk decisions and local Risk Management (RMPs)
- Effective communicator (written and oral); concise, accurate and business appropriate
- Proven ability to work cross-functionally.
- Demonstrates teamwork and initiative.
- Excellent attention to detail and be able to demonstrate and deliver high-quality work.

Specifically, this role has the following key responsibilities:

- Maintain expert knowledge of local pharmacovigilance regulations.
- Communicate impact of changes in local pharmacovigilance regulatory requirements to Patient Safety.
- Support the communication of safety related issues and information that may be of relevance to the identification of potential safety signals.
- Maintain expert local knowledge and oversight of:

- local submission of individual case safety reports to the regulatory authorities
- local submission of safety alerts to the regulatory authorities
- local studies and solicited programmes ongoing in the region and local post approval commitments.
- local literature review
- Support AHoPS to ensure the appropriate development and revision of local benefit / risk documentation and RMPs and risk-minimization activities.
- Ensure a proactive and strategic approach to PV locally through partnership with the Mexican affiliate e.g., annual literature review, oversight of local solicited programs, providing support and review of contracts to ensure alignment with global standards.
- Utilize and proactively participate in the Affiliate Patient Safety Network and access available Patient Safety resources such as the Agreement Repository, Patient Safety Shared drive and the Patient Safety SharePoint to ensure access to current information, including global PV Agreements, PBRERs/PSURs, RMPs and the Pharmacovigilance System Master File.

Management and Oversight of Local Quality Management System
- Maintain and input into local safety-related procedures, norms, resolutions and guidelines.
- Ensure availability of current organisation charts are up to date, local job descriptions, Curriculum Vitae and training records for safety personnel at the national level
- Train applicable staff and vendors on safety reporting procedures including the timely reporting of safety information, new hire training, sales and solicited programs training and ensuring all training is docum

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