Senior Manager, France Affiliate Patient Safety H/F
il y a 4 semaines
Gilead Sciences is seeking a highly skilled Senior Manager to join our France Affiliate team in the Patient Safety department. As a key member of our team, you will be responsible for providing support to the Affiliate Head of Patient Safety and global team to ensure strong engagement within the business, ensuring engagement and integration within the affiliate.
Key Responsibilities- Strategic PV partner: 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.
- 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.
- 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.
- Regulatory Intelligence & Industry Forums: Actively contribute to local industry forums, meetings, and seminars, maintaining expert knowledge of local pharmacovigilance regulations.
- 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.
- Pro-active PV forecasting: Act as the Patient Safety ambassador delivering proactive PV knowledge & support to the CPO and local Leadership Team.
- Local Programs and Research: Oversight of local studies and local commercial and medical affairs projects and perform pro-active plausibility assessments.
- Safety Monitoring: Maintain overview of medicinal product safety profiles and any emerging safety concerns for company products locally.
- Local Quality Management System: Ensure 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).
- Business Continuity: In collaboration with global Patient Safety, ensure local PV continuity plan in place and is exercised annually and maintained and communicated to global Patient Safety team.
- Pharmacist
- 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
- Fluent French essential
Gilead Sciences, Inc. and its subsidiaries and affiliates are equal opportunity employers and welcome applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion. We prohibit discrimination based on protected characteristics or prohibited grounds, including but not limited to, gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age.
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