Global Pv Icsr Manage

vor 3 Wochen

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 PV ICSR Manager is responsible for working across Sobi and case processing vendor functions to support the day-to-day management of single safety cases.

You will be working with internal Sobi experts and our case processing vendor teams to ensure Sobi safety case reports are processed and assessed to appropriate standards to ensure global reporting compliance and provide value for signal assessment. You address queries from the vendor teams, monitor quality and drive improvements to ensure that the ICSR activities are conducted to the highest quality standards in compliance with GVP, GCP and regulatory requirements. As part of our PV Global Case Management team you will be working collaboratively with the Global Case Management Lead, the PV Vendor Interface Manager, other Global PV ICSR Managers and PV Associates 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**
- Manage the PV Operation case processing mailboxes
- Guidance on ICSR-management investigations and issues raised by vendor
- Work with the Global Case Management Lead and PV Vendor Interface Manager to provide input and deliver process improvement
- Support the update to Case processing manuals and support delivery of training
- Responsible for Sobi out of process QC (sample focused QC to assess vendor quality) including feedback to vendor
- Subject matter expert for MedDRA coding including impact of non-valid terms in alignment with Safety Science Support the Global Case Management Lead in inspections and audits
- Pro-actively identify quality and compliance issues and support non-conformance investigations related to the vendor
- Perform/Coordinate reconciliation with Complaints, Medical Information, Market Research, Patient Support Programs and ISS
- Maintenance/Archiving of project sites / lists / Q&A / Trackers to keep information up-to-date
- Support RADAR (LSMV) configurations and user testing as required
- Support the ad hoc reconciliation of safety data
- Perform download from Authority Databases (e.g. EudraVigilance) or ensure vendor performs the activity (e.g. Health Canada)

**Qualifications**
- University level qualification in biosciences, healthcare, or pharmacy
- At least 3 years’ experience post-graduation in the pharmaceutical industry within the area of Pharmacovigilance.
- Thorough knowledge of regulatory Pharmacovigilance requirements during Clinical Trials as well as Post Marketing including Good Pharmacovigilance Practices (GVP) and ICH Guidelines
- At least 2 years’ experience of working with case processing activities in a safety database including triage, data entry and MedDRA coding
- 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 Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership._

**Location**

The position will be based in Flexible.

**Reporting to**

Global Case Management Lead
- Recruitment contact & how to apply_
- Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender

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