Head of Safety Science, Gpv

vor 5 Monaten

Basel, Schweiz Sobi Vollzeit

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.

Sobi employs approximately 1800 associates globally, with global headquarters in Stockholm and significant R&D hubs in Basel (Switzerland), Waltham (US) and Tokyo. (Sobi - transforming the lives of people with rare diseases)

**Role and Function**

At Sobi, we are transforming life for people with rare diseases. As an international biopharmaceutical company, we provide access to innovative treatments in the areas of hematology, immunology, oncology and specialty care. Sobi is a biopharmaceutical company with in-house capabilities that stretch from late-stage R&D, biologics manufacturing and supply, to patient access and distribution. We have a strong portfolio of on-market products, an extensive portfolio of pre-market assets, and a growing number of collaborations to bring medicines to more markets across the globe.

The Head of Safety Science will lead our global Safety Science team within Global Pharmacovigilance & Patient Safety (GPV). The Safety Science team is responsible to build the scientific and medical understanding of the safety of the products in the Sobi portfolio, to present that safety profile in the most appropriate forms and to work across the company to develop and implement measures to ensure the appropriate use of Sobi products.

The new Head of Safety Science role will fill an expanded role within Sobi Global Pharmacovigilance and Patient Safety (GPV), and we are looking for an individual with the experience, expertise and leadership skills to build the value of this role and to the drive the further development of our Sobi Safety Science team. The successful applicant will be responsible to lead this team and the development of the people, drive high quality and scientifically sound safety assessments, work collaboratively across Sobi PV and the wider Sobi business and to take a leading role improving our systems and processes.

**Key Responsibilities**
- Provide medical and scientific safety leadership to the Sobi portfolio, including the assessment of new assets and acquisition opportunities
- Lead our team of product assigned strategy Safety Leads and Safety Scientists, supporting them as they develop and maintain the safety profile of their assigned Sobi products. This team is approximately 20 associates, including experienced line managers
- Working closely across the Sobi business to understand the safety of products and manage and communicate safety information in a compliant, ethical and appropriate way to support patients, HCPs and Regulators.
- Focus the value that Safety Science brings to our development and marketed products, driving best practice as we support our Sobi clinical trial teams, product development teams and mature product teams
- Provide oversight and strategic direction to our external service providers preparing aggregate reports and implementing risk management approaches
- Collaborate closely with the GPV Management Team to ensure effective management of the PV function and good people management.
- Ensure compliance with health authority requirements, and take the lead in appropriate areas for inspections and audits and implement appropriate remediatiobn where required.
- Provide backup to Head of Global Pharmacovigilance and medical support to the QPPV
- Be a member of key member of the GPV leadership team, together with clinical, safety and labelling committees

We are looking for a motivated and collaborative professional, with demonstrated leadership and people development skills. The Head of Safety is a key role for us in Sobi GPV to help shape our team, drive our systems and processes and drive effective collaboration and decision making across Sobi and with our partners.

**Qualifications**
- Doctor of Medicine (M.D.). Medical Degree with a medical specialisation. Post graduate qualification in pharmaceutical medicine or other relevant areas is preferred.
- At least +8 years of experience in global medical safety/ pharmacovigilance roles in a global pharmaceutical company, working with development programs and with products with market approvals
- Proven leadership and line management experience and skills within a medical safety or similar setting
- Advanced knowledge of PV regulations and cross-functional working.

**Personal Attributes**
- Strategic vision and ability to work with a team to successfully deliver
- Ability to work effectively to deliver ambitious goals
- Work collaboratively in various cross-functional settings and as part of matrix teams
- Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive, and decisive
- Relationship builder both internally and externally, a s

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