Global Product Safety Science Lead

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

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

Additional Information :

Compensation and Total Rewards at Sobi

At Sobi we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent ensuring that your contributions are valued and reflected in your overall rewards.

The base salary range for this role is $170000-$200000. Each individual offer will be determined based on several factors including your experience qualifications and location. Additionally this role is eligible for both short-term and long-term bonuses as outlined in the plan details.

All Sobi employees need to demonstrate behaviors in line with Sobis core values: Care Ambition Urgency Ownership and Partnership. Are you ready to be on the Sobi team Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us

We are a global company with over 1900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

Sobi Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An 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   

Remote Work :

Yes

Employment Type :

Full-time