Global Product Safety Science Lead

Full-time

Sobi Location: Sweden

**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._

At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.

As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.

We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.

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.

**Key Responsibilities/Scope of the Job**
- Lead the product level multidisciplinary Benefit Risk Team (BRT) to drive signal detection, analysis and validation, risk management and minimization strategies, risk communication, and safety labelling
- Initiate BRTs for products in development (if applicable starting before the first-in-human study) and for post approval products
- Act as a Chairperson of the BRT and therefore be accountable for the BRT benefit-risk evaluation and represent the BRT at Benefit Risk Council Meetings. Ensure the operation of the BRT per SOP
- Together with the BRT, set the strategy for safety signal detection methodology, signal tracking and oversight of safety signals
- Ensure the quality of signal assessments prepared by BRT
- Accountable for benefit-risk evaluation and ensuring appropriate risk minimisation and effectiveness measures are in operation, as described in the Risk Management Plan (RMP)
- Lead the Safety Science contribution for clinical development including providing clinical safety input to design, conduct, data analysis and interpretation. May directly fill the role of study level Safety Lead, or may work with a safety scientist as they fill the study level Safety Lead role for assigned studies. The study level Safety Lead works in close collaboration with PV Operations to ensure appropriate clinical study case processing is delivered
- The study level Safety Lead responsibilities include the preparation of Safety Management Plan in collaboration with the Partnership & Operations Manager, interpretation of safety data, participating in scientific discussions related to safety, development of documents (e.g. protocols and end-of-study reports).
- Lead the clinical safety science interactions with partner companies for the product (if applicable) including ensuring sharing of safety information per the SDEA and the collaborative functioning of the JSMT
- Proactive and effective communication with product level stakeholders related to clinical safety including MDL, CAT lead, GRA lead, and GPV Management including Safety Science management, QPPV and Head GPV
- Work effectively with the product assigned GPSS to complete safety deliverables across assigned projects. This means working collaboratively and flexibly to complete activities and to ensure continuity of safety science support
- Lead the development and implementation of signal management activities
- Provide medical and pharmacovigilance expertise e.g. for the clinical safety strategy of the product clinical development program, the development of the Target Product Profile (TPP), setting the clinical study safety standards, the development and maintenance of the RSI, including IB and CDS
- For assigned products, contribute to the analysis planning and medical thinking, and support the preparation (as required), and approval of product safety information in documents such as regulatory-required reports, medical information responses, response documents, publications, and information for external meetings
- Provide the strategic/medical direction for periodic reports including review and approval including being a key contributing author for documents describing the benefit risk of assigned products
- Review safety-related scientific literature and pr