US Pharmaceutical Safety Specialist
2 semanas atrás
This position is a key role in ensuring the safety of pharmaceutical products.
The job holder will be responsible for maintaining a comprehensive understanding of FDA and regional regulations. They will support the local safety team by initiating, planning, executing, controlling, and closing projects. The role also involves engaging regularly with internal and external stakeholders to ensure accuracy, completeness, and issue resolution.
In addition, the successful candidate will ensure adherence to processes and maintain relevant documentation. They will assess the impact of changes on safety requirements and coordinate with stakeholders for timely decisions. Unresolved issues will be escalated following the established process. Quality and turnaround time targets must be consistently met.
The ideal candidate will have strong attention to detail and excellent communication skills in English (verbal & written). Experience in team management and understanding of business principles are essential. A university degree in Life Sciences or Pharmacy is required, along with at least 10 years of experience in pharma/biotech, including 6 years in US FDA regulations and project management. Personal initiative, responsibility, flexibility, and ability to handle multiple projects independently are also necessary.
Key Responsibilities:- Maintain regulatory knowledge and compliance;
- Support local safety team projects and initiatives;
- Ensure stakeholder engagement and issue resolution;
- Document and report on project progress and results;
- Evaluate impact of changes on safety requirements;
- Escalate unresolved issues following established procedures;
- Strong analytical and problem-solving skills;
- Excellent communication and interpersonal skills;
- Ability to work in a team environment;
- Proven track record of meeting quality and turnaround time targets;
- Experience with regulatory compliance and project management.
- Health and life insurance;
Gympass;
Support programs including psychological, legal, social, and financial assistance;
Partnerships with educational and training institutions;
Reimbursement for certifications;
Access to learning portal;
International experience opportunities;
Referral bonuses and recognition programs.
We are an equal opportunity employer committed to diversity and inclusion. We welcome candidates from all backgrounds and encourage participation in our recruitment process. Join us and be part of an inclusive culture that respects individuality and promotes equity across gender, disability, LGBTQIA+, religion, race, and ethnicity.
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