Global Product Safety Science Lead

Job Description 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. This is a US based position – candidates need to be located on the US East Coast, preferably close to the Raleigh, NC office. 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 Education / Learning Experience / Work Experience 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) 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 Compensation and Total Rewards Base salary range for this role is $170,000–$200,000. Each individual offer will be determined based on several factors, including experience, qualifications, and location. Additionally, this role is eligible for both short‑term and long‑term bonuses, as outlined in the plan details. Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to View email address on click.appcast.io. #J-18808-Ljbffr Sobi