Global Product Safety Scientist

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.

Job Description

The Global Safety Scientist has a key role within Global Pharmacovigilance & Patient Safety (GPV) and is responsible for providing scientific expertise to safety surveillance and risk management activities including signal detection and evaluation for assigned product(s), where Sobi is the marketing authorisation holder or has product(s) in clinical development. The role actively contributes to setting the strategic direction within GPV and to the development of safety standards and processes.

As part of our PV team you will be working collaboratively with the Global Product Safety Science Lead (GPSSL) for assigned product(s) as well as with other PV functions, to ensure that safety surveillance activities are delivered to ethical and safety quality standards to ensure the safety of patients and to be in compliance with GVP, GCP and worldwide regulatory requirements. You will also be working cross functionally within the company and with 3rd parties.

We are looking for a motivated and collaborative professional who will contribute to shaping our team, develop our systems and processes and drive effective collaborations across Sobi and with our partners.

Responsibilities

The Global Product Safety Scientist is directly responsible for providing scientific expertise to safety surveillance and risk management activities for one or more Sobi development and/ or marketed products. You will be part of a collaborative team made up of safety leads and safety scientists. Key responsibilities include but are not limited to:

• For the assigned product(s) coordinate multidisciplinary product level Benefit Risk Team meetings for signal detection, analysis and validation, risk management and minimization strategies, risk communication, and safety labelling activities
• Contribute to clinical safety science interactions with partner companies for the product (if applicable) to ensure effective clinical safety science interactions including ensuring sharing of safety information per the SDEA and the collaborative functioning of the joint safety management team (JSMT)
• Create, extract and/or prepare all types of listings from data sources required from the Sobi Safety Database, or other applicable sources, for the purpose of signal detection, safety surveillance/analysis and regulatory submission activities.
• Lead the collection of material for periodic reports e.g. PSURs and DSURs and contribute to the risk evaluation and the benefit-risk assessment for the assigned product(s).
• Be main author and coordinator for the production and maintenance of core and EU RMPs and work with stakeholders to support the preparation and maintenance of local RMPs
• Provide high quality and timely contributions to responses to safety-related enquiries for Sobi products i.e. from regulatory authorities and other sources requiring input from GPV.
• Be the safety representative in clinical study teams, including providing safety input to design, conduct data analysis and interpretation. Work in close collaboration with PV Operations to ensure appropriate study case processing.
• Provide safety expertise to CTD submission, regulatory interactions and defence, and geo-expansion beyond initial License Applications (NDA/BLA) and MAAs
• In alignment with the GPSSL drive monitoring, aggregation, review, analyses, interpretation, and evaluation of incoming safety information and highlight potential safety signals
• Work collaboratively, effectively and flexibly with the GPSSL to complete safety deliverables and activities to ensure continuity of safety support
• Work across PV with the product assigned Partnership and Operations Manager to contribute to product specific case management guidance documents and trainings e.g. Product Safety Information
• Contribute to development and maintenance of safety related systems, processes, and procedural documents
• Support audits and inspections for pre-inspection requests as well as during audits and inspections

Qualifications

Education/Learning Experience/Work Experience

• University level qualification in biosciences, healthcare, or pharmacy. A PhD in a topic relevant to the position is preferred
• At least 3 years´ experience post graduation in the pharmaceutical industry, preferably in Patient Safety and/or Clinical/Drug Development, or at a regulatory agency
• Previous experience in Pharmacovigilance, including advanced/solid knowledge of PV regulations and cross-functional working

Skills/Knowledge

• Analytical skills
• Ability to work proactively, independently, and collaboratively with colleagues
• Team-leadership capabilities.
• Relationship builder and collaborator within PV functions Experience, expertise, determination, and courage to solve problems or escalate issues as appropriate
• Effective communicator with peers, internally and with partner functions
• Preferred experience in process development, process implementation, training development and process oversight
• High quality written and spoken English

Personal Attributes

• Problem solver, developer of analysis and deliver plans. Proven delivery focus
• Effective team player

Additional Information

All Sobi employees need to demonstrate behaviors in line with Sobi's 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 1,700 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, we're ready to take on the world's diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here. If you're 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 can't 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.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. 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 talentacquisition@sobi.com.