Global Pv Icsr Manage

vor 6 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 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

  • Global Pv Case Management Lead

    vor 6 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,...

  • Global Pv Partnership

    vor 7 Monaten

    Basel, Schweiz Sobi Vollzeit

    **Role and 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...

  • Global Pv Systems Lead

    vor 6 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,...

  • Countries and Regions Pv Manager

    vor 6 Monaten

    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 sphere. This...

  • Pv Partnership

    vor 6 Monaten

    Basel, Schweiz Sobi Vollzeit

    **Role and 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...

  • Director, Pv Operations

    vor 2 Monaten

    Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract 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...

  • Director, PV Operations

    vor 2 Wochen

    Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract 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 systems. We...

  • Global Head Pharmacovigilance QA

    vor 2 Wochen

    Basel, Schweiz Healthcare Businesswomen’s Association Vollzeit

    Job Description Summary Location: Basel, Switzerland (80-100%)Working model: Hybrid working model (12 days per month in the office) The Pharmacovigilance Quality Assurance (PVQA) organization within the Development Quality organization supports Novartis Patient Safety & Pharmacovigilance Department. In this role, you will provide comprehensive expertise and...

  • Pharmacovigilance Associate

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Teva Pharmaceuticals Vollzeit

    Job DescriptionMepha Schweiz Ltd is currently seeking a skilled Pharmacovigilance (PV) Associate to support the Head of Pharmacovigilance Switzerland and Local Safety Officer in maintaining the local Pharmacovigilance System. As a Deputy Local Safety Officer, this individual will collaborate closely with the PV cluster, regional, and global Pharmacovigilance...

  • Director, PV Operations Basel, Switzerland | Full-Time | Permanent

    vor 2 Wochen

    Basel, Schweiz Vectura Group Vollzeit

    Who We AreVectura 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 systems.We are driven by the exciting and unique goal of addressing unmet...

  • Global Product Safety Scientist

    vor 5 Monaten

    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 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...

  • Global Safety Scientist

    vor 6 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 and Function** At...

  • Global Procurement Manager

    vor 6 Monaten

    Basel, Schweiz Jet Aviation Vollzeit

    We are seeking a highly skilled and experienced Global Procurement Manager to oversee our companys contracts and manage the related process across multiple regions and jurisdictions. The Global Procurement Manager will be responsible for identifying global contract opportunities and synergies, ensuring compliance with contractual obligations, mitigating...

  • Global Contract Manager

    vor 5 Monaten

    Basel, Schweiz Hawker Pacific Vollzeit

    Summary: Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel, Switzerland, to some 4,000 employees, and some 50 locations worldwide. Aircraft Management, Aircraft Sales, Charter, Completions, Defence, FBO, Fixed and Rotary Wing Maintenance, and Staffing. Behind every seamless Jet Aviation experience, is a team of...

  • Global Contract Manager

    vor 5 Monaten

    Basel, Schweiz Jet Aviation AG Vollzeit

    We are seeking a highly skilled and experienced Global Contract Manager to oversee our company's contracts and manage the related process across multiple regions and jurisdictions. The Global Contract Manager will be responsible for identifying global contract opportunities and synergies, ensuring compliance with contractual obligations, mitigating risks,...

  • Global Payroll Operations Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Job SummaryWe are seeking a highly skilled Global Payroll Operations Manager to join our team in Basel, Switzerland and Manchester, UK. As a key member of our global payroll operations team, you will be responsible for the end-to-end processes related to payroll and time management.

  • Project Manager

    vor 6 Monaten

    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...

  • Global Transformation Program Manager

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Straumann Group Vollzeit

    Job SummaryWe are seeking an experienced Global Transformation Program Manager to lead our digital transformation programs and align stakeholders.Main ResponsibilitiesDefine program scope, goals, and outcomes in line with business objectives.Develop comprehensive plans, manage budgets, and allocate resources efficiently.Lead cross-functional teams and...

  • Quality Assurance and Pharmacovigilance Expert

    vor 5 Monaten

    Basel, Schweiz ALTOGEN AG Vollzeit

    **COMPANY** **ALTOGEN** is a Swiss engineering and consulting company specialized in life sciences with expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to...