Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

The Global Product Safety Science Lead (GPSSL) is responsible to strategically lead the Safety Science activities for assigned Sobi products.  The GPSSL leads the safety science engagement throughout the product lifecycle including the development and maintenance of the clinical safety profile of the product, the ongoing safety surveillance and management, and the effective and timely communication of clinical safety to internal and external stakeholders.  The GPSSL works collaboratively with the Global Product Safety Scientist (GPSS) and other members of the Sobi Global Pharmacovigilance team, together with other functions across Sobi, to ensure that safety science activities are delivered to ethical and safety quality standards to ensure safety of patients, and compliance with GVP, GCP and worldwide regulatory requirements.

Key Responsibilities:

1. Lead the product level multidisciplinary Benefit Risk Team (BRT) to drive signal detection, risk management, and safety labelling.
2. Represent Safety Science at the product level Medical Development Team as a key subject matter expert.
3. Lead Safety Science contribution for clinical development, including providing clinical safety input to design, conduct, data analysis, and interpretation.
4. Manage clinical safety science interactions with partner companies, ensuring sharing of safety information.
5. Develop and implement signal management activities.
6. Provide medical and pharmacovigilance expertise for clinical safety strategy, Target Product Profile (TPP), and Reference Safety Information (RSI).
7. Contribute to analysis planning, medical thinking, and preparation of product safety information for various documents and reports.
8. Lead Safety Science input for post-marketing activities, including PASS-studies and additional risk minimisation measures.
9. Provide safety expertise for regulatory submissions, interactions, and geo-expansion.
10. Support audits and inspections, and represent Global Pharmacovigilance in interactions with internal and external stakeholders.
11. Collaborate with cross-functional teams to ensure alignment on safety strategies and risk management plans.
12. Stay updated on global regulatory requirements and industry best practices in pharmacovigilance and product safety.
13. Mentor and provide guidance to junior safety scientists within the team.
14. Participate in and contribute to scientific conferences and publications related to product safety and pharmacovigilance.
15. Develop and maintain strong relationships with key opinion leaders and external experts in the field of product safety.

Required:

• Higher level biomedical or scientific qualification (e.g., MD, PharmD or PhD)
• Minimum 8 years of relevant clinical practice, research experience, and/or employment in Drug Regulatory Agency or Pharmaceutical Industry R&D
• At least 5 years involvement in signal evaluation and benefit/risk assessment of medicines in a global pharmaceutical company or Drug Regulatory Agency
• Experience leading cross-functional global product safety management teams
• In-depth knowledge of pharmacovigilance processes, practices, and regulations (e.g., GCP and GVP)
• High quality written and spoken English
• Strong team-leadership capabilities and collaborative skills
• Sound judgement and ability to assess and handle risks

Desired:

• Experience working with partner companies in global markets
• Experience presenting medical safety information at Health Authority meetings
• Expertise in various country/regional pharmacovigilance requirements