Global Product Safety Science Lead
Vor 3 Tagen
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.
Job DescriptionThe 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:
- Lead the product level multidisciplinary Benefit Risk Team (BRT) to drive signal detection, analysis, risk management, and safety labelling.
- Represent Safety Science at the product level Medical Development Team, providing pharmacovigilance and clinical safety expertise.
- Lead Safety Science contribution for clinical development, including input on design, conduct, data analysis, and interpretation.
- Oversee clinical safety science interactions with partner companies, ensuring sharing of safety information.
- Lead development and implementation of signal management activities.
- Provide medical and pharmacovigilance expertise for clinical safety strategy, Target Product Profile (TPP), and regulatory documents.
- Lead Safety Science input for post-marketing activities, including PASS-studies and additional risk minimisation measures.
- Support regulatory submissions, interactions, and product expansion activities.
- Respond to medical safety-related enquiries and support audits and inspections as required.
- Represent Global Pharmacovigilance in interactions with internal and external stakeholders, including Regulatory Authorities and Key Opinion Leaders.
Education/Learning Experience/Work Experience
Required:
- Higher level biomedical or scientific qualification (e.g., MD, PharmD or PhD)
- 8+ years of relevant clinical practice, clinical research experience and/or employment at a Drug Regulatory Agency or R&D in the Pharmaceutical Industry
- 5+ years involvement in assessment of signal evaluation and benefit/risk of medicines in a global pharmaceutical company or a 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)
Desired:
- Experience working with partner companies in global markets
- Experience presenting medical safety information at Health Authority meetings
Skills/Knowledge/Languages
Required:
- Fluency in written and spoken English
- Strong communication and team-leadership capabilities
- Sound judgment skills and ability to assess and handle risks
- Expertise in resolving or escalating issues as appropriate
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