Associate / Senior Associate Drug Safety Licensing (m/f)

- Responsible for writing and implementing Safety Agreements for any commercial arrangement and/or clinical studies / programs between client and its partners as appropriate, per DSL templates ,guidances and standard operating procedures
- Mentoring and coaching of a DSL manager, contribute to due diligence activities, draft, negotiate and implement the appropriate Pharmacovigilance agreements (PVAs)
- Bachelor's Degree in life science / health care degree (or equivalent through experience) with a proven experience of some years in Pharmacovigilance
- Proven experience in Drug Safety Licensing activities
- Knowledge and understanding of FDA and ICH regulations and guidelines
- Proven excellent written and verbal communication skills with an international or cross functional perspective, able to represent client internally and externally
- Excellent command of English
- Knowledge and understanding of FDA, EU Pharmacovigilance Legislation and related regulatory documents, ICH guidelines and national/international GCP requirements
- Excellent problem-solving, analytical, impact assessment and strategic thinking skills
- Detail oriented
- Ability to work independently, and contribute as a team member
- Ability to simultaneously work on several projects at the same time
- Good time management
- Solution oriented
- Excellent negotiation skills
- Ability to collaborate and communicate effectively and efficiently in an international matrix environment

Weitere Qualifikationen: Drug safety officer