At a Glance
- Tasks: Lead safety science activities for innovative pharmaceutical products and ensure patient safety.
- Company: Join Sobi, a global leader in specialty pharmaceuticals for rare diseases.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on ethical standards and regulatory compliance.
- Why this job: Make a real difference in patients' lives while working with cutting-edge science.
- Qualifications: Advanced biomedical degree and extensive experience in clinical safety and pharmacovigilance.
The predicted salary is between 36000 - 60000 £ per year.
Company Description 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
- 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.
Qualifications
- 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
- 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
Global Product Safety Science Lead in Cambridge employer: Sobi - Swedish Orphan Biovitrum AB (publ)
At Sobi, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our commitment to employee growth is evident through continuous professional development opportunities and a supportive environment that encourages cross-functional teamwork. Located in a vibrant setting, we offer competitive benefits and the chance to make a meaningful impact in the field of biopharmaceuticals, ensuring that our employees feel valued and engaged in their work.
Contact Details:
Sobi - Swedish Orphan Biovitrum AB (publ) Recruitment Team
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