Aktuelle Jobs im Zusammenhang mit Global Pv Icsr Manage - Basel - Sobi
-
Pharmacovigilance (Pv) Operations Manager
vor 1 Woche
Basel, Schweiz Takeda Pharmaceutical VollzeitAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a** **Pharmacovigilance (PV) Operations Manager** in our Zurich office. **Here, you will be a vital contributor to our inspiring, bold mission.** The Vaccine Pharmacovigilance Operations Manager provides support to Takeda’s Vaccine...
-
Director, Pv Operations
vor 1 Woche
Basel, Schweiz VECTURA FERTIN PHARMA VollzeitContract Type: Permanent Closing date: Reference: VN1884 - Who We Are Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery...
-
Pharmacovigilance QA Manager
Vor 7 Tagen
Basel, Basel-Stadt, Schweiz Hydrogen Group VollzeitOverviewWe are searching for an experienced QA leader to oversee global Pharmacovigilance quality activities. You will drive the PV audit strategy, strengthen affiliate PV systems, ensure inspection readiness, and work closely with the EU QPPV and local safety teams.ResponsibilitiesLead the global PV audit program for internal processes, partners, and...
-
Pharmacovigilance Global Signal Management
vor 1 Woche
Basel, Basel-Stadt, Schweiz Planet Pharma VollzeitAssociate Director – Global Signal Management | Pharmacovigilance Leadership OpportunityAre you passionate about patient safety and driving innovation in pharmacovigilance? We're looking for a strategic leader to own and evolve global signal management processes across a diverse product portfolio.In this high-impact role, you'll: Lead global signal...
-
Global Product Safety Scientist
vor 2 Wochen
Basel, Schweiz Sobi Vollzeit**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...
-
Global Safety Scientist
vor 2 Wochen
Basel, Schweiz Sobi VollzeitSobi 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 and Function** At...
-
Global Lead Contract
Vor 6 Tagen
Basel, Schweiz Global Personal Partner Vollzeit**EINFÜHRUNG**: Our profession and our passion "HR Management." Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of human resources services at 21 locations in German-speaking Switzerland. For our client, an international orientated Pharma company in Basel, we are looking for a reliable...
-
Project Manager, Branding
vor 2 Wochen
Basel, Schweiz Art Basel VollzeitProject Manager, Branding & Signage (Global) Basel, Switzerland This position is offered as a 12‑month temporary contract, with the possibility of renewal or transition into a permanent role. The Project Manager in Branding & Signage is in charge of the project management and operational execution of branding, signage, and wayfinding concepts for the Art...
-
Global Program Manager
vor 1 Tag
Basel, Schweiz We make it VollzeitBeschreibung: We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the...
-
Global Community
Vor 3 Tagen
Basel, Schweiz Institut Straumann AG VollzeitJob Purpose The Global Community & Engagement Manager - Beginner Implantology is a strategic and community-driven role designed to attract, inspire, and retain the next generation of implantologists. Acting as a bridge between education, clinical mentorship, and global networking, this position ensures that new learners—whether students, recent graduates,...
Global Pv Icsr Manage
vor 3 Wochen
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
