Global Product Safety Science Lead

vor 4 Wochen

Basel, Schweiz Sobi Vollzeit

Role & Function

The Global Product Safety Science Lead is a key role within Global Pharmacovigilance (PV) and Patient Safety. You will be leading the safety surveillance activities for assigned marketed Sobi products and for products under development. As part of our PV team, you will be working collaboratively with other PV functions to ensure that safety surveillance activities are conducted to the highest ethical and safety quality standards in compliance with GVP, GCP and worldwide regulatory requirements. As the lead of the Benefit Risk Team and a member of the Medical Development Team you will have a key role in shaping the clinical development, medical safety positioning and regulatory interactions throughout the product lifecycle.

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.

Key Responsibilities
- Safety signal management from all sources for assigned products
- Ensure the Company Core Safety Information (CCSI) for assigned product(s) is timely and accurate
- Lead the multidisciplinary product level Benefit Risk Team (BRT) meetings to drive signal detection and validation, risk management and minimization strategies, risk communication, and safety labelling
- For assigned products, prepare (as required), review, and approve product safety information in all ad hoc documents or regulatory-required periodic reports requiring medical review and interpretation, including providing medical opinion on all relevant documents prior to submission to regulatory authorities, journals and external meetings, and provide medical input to protocols and end-of-study reports.
- Represent Safety Science in the design, conduct and completion of clinical studies, being a key member of the product level Medical Development Teams
- Represent Global Pharmacovigilance & Patient Safety in interactions with internal and external business partners, Regulatory Authorities, Advisory Boards, HCPs, and Key Opinion Leaders

**Qualifications**:

- Higher level biomedical or scientific qualification (e.g. MD, PharmD or PhD)
- Experienced Safety Science professional including but not limiting to the following:

- A total of 8 years of relevant clinical practice, clinical research experience and/or employment at a Drug Regulatory Agency and/or R&D in the Pharmaceutical Industry
- At least 5 years involvement in assessment of signal evaluation and benefit/risk of medicines in a global pharmaceutical company or a Drug Regulatory Agency
- Experience working with development programs and with products with market approvals
- Experience leading cross functional global product safety management teams, successfully delivering medical safety strategy, with experience across single medical case review, the safety signal process, aggregate report writing, safety risk communication and safety risk management
- In-depth knowledge and experience of pharmacovigilance processes, practices, and regulations e.g., GCP and GVP.
- Knowledge of the Pharmaceutical Industry, especially clinical research, and global regulatory requirements
- Ability to bring together medical knowledge and compliance with industry standards to safeguard patients, and support the delivery business goals

Personal attributes
- Ability to work effectively to fulfil ambitious goals
- Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive and decisive
- Strong team-leading leadership capabilities. Demonstrated relationship builder both internally and externally; a strong collaborator within PV function, leadership and the wider organisation
- Effective communicator at all levels of the business
- Has the expertise, determination and courage to resolve or escalate issues as appropriate
- Ability to balance medical knowledge with industry standards to achieve business goals
- Work collaboratively in various cross-functional settings and as part of matrix teams

In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

**Why Join Us?**

We are a global company with around 1,500 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

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