Global Safety Risk Management Lead

vor 8 Monaten

Basel, Schweiz Sobi Vollzeit

**Role & 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 haematology, 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. The role of the Global Safety Risk Management Lead is to lead the organisations efforts in developing effective and efficient Risk Management (RM) processes and systems, including additional Risk Minimisations (aRMMs) for applicable Sobi products. As part of our PV team, you will be working collaboratively with other PV functions and cross functionally both at global and local level and with external consultants, to ensure that the Risk Management activities are conducted to the highest ethical and safety quality standards in compliance with GVP and regulatory requirements. We are looking for a motivated and collaborative professional who will contribute to develop our systems and Risk Management processes, including and drive effective collaborations across Sobi and with our partners. As the Global Safety and Risk Management Lead you will be reporting to the Global Head of Safety Science at the Global Pharmacovigilance and Patient Safety (GPV) department.

**Key Responsibilities**
- Development and ongoing review of the RM processes for Risk Management Plans and additional Risk Minimisation Measures (including controlled distribution), ensuring that processes are well documented, communicated, recorded, and monitored through appropriate compliance and performance indicators
- Lead the preparation of appropriate training and, through Sobi systems, ensure that training in risk management and risk minimisation processes are delivered to appropriate Sobi associates.
- Work with members of the Safety Science Team, together with members of the product level in the Medical Development Teams and the Core Asset Teams, to design and develop appropriate risk management and aRMMs for applicable products in both the development and post-authorisation phase.
- Liaise with global and affiliate staff and external service providers to ensure that required RM and aRMMs are appropriately implemented and maintained at global and local levels, including appropriate tracking and effectiveness measures.
- Provide regular updates to EU QPPV, Head of Global Pharmacovigilance and Patient Safety and other stakeholders on the progress of implementation of aRMMs and performance indicators
- Ensure any identified non-compliances related to RM aRMMs are notified/ documented by the program owner according to company processes, and that remedial actions are implemented and tracked to completion
- Act as internal resource/expert on the regulatory requirements for risk management globally. Maintain current knowledge on the requirements for risk management by attendance at appropriate trainings, conferences etc, in agreement with line manager
- Contribute to the maintenance of the PSMF as required
- Lead efforts to assess and develop technologies to improve the provision of RM and aRMM activities. For identified projects serve as SME and/or project lead as appropriate

**Qualifications**
- Biomedical or scientific qualification (MSc, PharmD or PhD)
- Established experience in pharmacovigilance with experience at both global and regional/ local level preferred
- Expertise in international regulations relevant to pharmacovigilance and safety risk management
- Proven experience of RMP development and implementation and the design and implementation of aRMM
- Proven ability to work effectively with collaboratively colleagues and influence across the organisation at a senior level
- Preferred experience in process development, process implementation, training development and process oversight
- Preferred experience with working with external vendors to develop and implement PV relevant IT solutions

**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
- Demonstrated relationship builder both internally and externally
- Strong collaborator within PV function 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
- Work collaboratively in various cross-functional settings and as part of matrix team In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

**Location**

The position will be based in Stockholm/Sweden or Basel/Switzerland

**Reporting to**

Head of Safety Science
- Recruitment contact & how to apply_
- Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive con

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