Global Pv Case Management Lead

vor 7 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.

**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 Global Case Management Lead leads our Sobi Case Management team, reporting into the Head of PV Systems and Operations. You and your team will ensure our processes and conventions for case processing are optimized, you will drive the performance of our case processing vendors and you will work with our partners to deliver high quality and compliant single case safety reports.

You will be accountable for oversight, development and improvement of the case processing activities, including pro-active management and oversight of our case processing-vendors. You will take the lead for assuring quality & compliance for Sobi ICSRs. As part of our PV Systems and Operations management team you will be working collaboratively with the Head of PV Systems and Operations, PV Systems Lead and PV Partnership & Operations Lead to ensure that the ICSR activities are conducted to the highest quality standards in compliance with GVP, GCP and regulatory requirements. 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 partner.

**Key Responsibilities**
- Lead and develop the Global Case Management team including people management and ensuring clear roles & responsibilities for the team
- Accountable for vendor oversight, including quality and compliance of cases, support budget review and strategies of tasks outsourced to ICSR processing vendor.
- Management of roles and responsibilities between Sobi team and case processing vendors
- Serve as the Global Process Owner of the ICSR processes
- Responsible to ensure Sobi Case Management process is in line with current global regulatory requirements for Safety operational activities and support. the interpretation and implementation of new or existing legal requirements
- Oversight of the Global literature process including translations
- Owner of the Sobi Product level case processing Safety Information documents (PSI) in collaboration the product level PV Partnership & Operations Manager and the product Safety Lead
- Responsible for ensuring effective case processing training is delivered
- Responsible for maintaining the reporting matrix for distribution rules
- Setting the strategy and oversight for the reconciliation activities
- Business Super User in the Sobi PV database, responsible to provide business input on release management assessments and assure user testing as required
- Lead for audits and inspections related to Case Management. Responsible for inspection readiness for Case Management

**Qualifications**
- University level qualification in biosciences, healthcare or pharmacy
- At least 8 years of relevant work experience in Pharmacovigilance within the pharmaceutical industry
- At least 5 years involving case management including safety database configurations to meet PV business needs and regulatory reporting
- 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
- Experience in managing and supervising internal and external teams, including managing and overseeing vendor case processing teams
- Strong organizational, planning, prioritizing and problem-solving skills
- Desired: Working knowledge of ArisGlobal LifeSphere MultiVigilance system

**Personal attributes**
- Ability to work effectively to deliver ambitious goals - Work collaboratively in various cross-functional settings and as part of matrix teams
- Ability to work proactively, independently, and collaboratively with colleagues
- Relationship builder both internally and externally, a strong collaborator within PV function and the wider organisation
- Has the experience, expertise, determination, and courage to problem solve or escalate issues as appropriate
- Analytical skills
- Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive, and decisive
- Preferred experience in process development, process implementation, training development and process oversight.
- In addition, you must demonstrate behaviors in line with Sob

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