Countries and Regions PV Manager

vor 1 Woche

Basel, Basel-Stadt, Schweiz Sobi Vollzeit
Job Description

This position plays a crucial role in supporting the efficient delivery of Sobi pharmacovigilance across Sobi countries and regions.

Reporting to the Head of Countries & Regions, QPPV and closely collaborating with the Countries & Regions team, the Countries and Regions PV Manager is a vital member of the GPV organization focusing on:

  • The Sobi GPV outreach strategy to Sobi country and regional PV, developing, supporting, and driving excellence in post-approval pharmacovigilance activities related to Sobi and its partner products, to ensure local compliance with Sobi/Partner PV system requirements.
  • Providing input to Sobi's geo-expansion activities, to ensure timely implementation of a robust, compliant, and efficient PV system for new products and new markets.
  • Interacting with vendors contracted to carry out local and regional PV activities to enhance local Pharmacovigilance (PV) performance, ensuring compliant, effective, efficient, and business-appropriate standards and processes, and supporting oversight and audit/inspection readiness.
  • Facilitating and communicating PV-related activities and projects between GPV and local teams.

Key Responsibilities:

  • Contributing to the effective business interface between Sobi GPV and strategic vendors for Sobi local and regional PV activities, including overseeing vendor compliance in assigned countries.
  • Working closely with Sobi global function stakeholders and local Sobi teams to ensure effective communication, collaboration, and issue resolution.
  • Being the point of contact for GPV and other teams for assigned countries.
  • Promoting and implementing continuous improvement activities across all areas related to countries and regions PV activities to optimize quality and productivity, including process improvement and CAPA management and implementation.
  • Working closely with Global Process Owners to ensure local implementation of global pharmacovigilance procedures.
  • Being the primary GPV point of contact for local teams for Pharmacovigilance aspects in assigned countries.
  • Ensuring strong relationships with country PV staff to maximize opportunities for Pharmacovigilance, Sobi/partner products, and patients.
  • Identifying, assessing, and escalating risks related to country pharmacovigilance activities to the Head of Countries & Regions, QPPV, and other teams as appropriate, and contributing to implementing actions to address identified risks.
  • Ensuring compliance with processes for quality oversight of local PV activities, including outsourcing activities, review of local PV-related Standard Operations Procedures (SOPs), training, and implementation of PV-related SOPs and procedures, local literature review, aRMM, and other activities supported by Sobi local PV contacts through interaction with Global Process Owners.
  • Being responsible for ensuring CAPAs related to PV activities in the assigned countries are appropriate to the issue concerned and closed on time.
  • Maintaining a high degree of understanding and awareness of new Pharmacovigilance trends and developments and collaborating with GPV, local PV, and vendors to ensure Sobi PV activities remain current.
  • Supporting the management and maintenance of the Pharmacovigilance System Master File (PSMF) including local and partner PSMFs, through delivering regional PV information as required by the PSMF Coordinator.

Global process development and management

  • Contributing to the continuous improvement of GPV processes, systems, and standards.

Inspection/Audits

  • Contributing to the GVP audit strategy and audit schedule.
  • Supporting the PV audit and inspection readiness activities at the local level.
  • Supporting PV inspections and audits (internal/external), including pre-inspection/audit request and support during inspections/audits.
  • Supporting responses and CAPAs to inspections and audits with a focus on affiliate level and managing the closeout of CAPAs.
Qualifications

Education/Learning Experience/Work Experience

Required:

  • University-level qualification in biosciences, healthcare, or pharmacy.
  • At least 5 years of professional work experience in the Pharmaceutical industry with a minimum of 2 years of experience within the Pharmacovigilance department.

Desired:

  • Pharmacovigilance experience from working within both the local and global levels.
  • System and process development, implementation, and improvement.

Skills/Knowledge/Languages

Required:

  • Expert knowledge of PV-related regulatory requirements, including an understanding of PV processes and international guidelines (including Good Pharmacovigilance Practices (GVP) and ICH Guidelines).
  • Working across teams to develop a holistic understanding of situations and requirements, in order to deliver solutions that work across stakeholders.
  • Being a strong collaborator and problem solver.
  • Quality mindset including CAPA management.
  • Fluency in English.
  • Computer literate.
Additional Information

Personal Attributes

Required:

  • Strong communication skills, including across geographies and functions.
  • Strong analytical/problem-solving skills and attention to detail.
  • Ability to manage multiple activities simultaneously.
  • Ability to independently plan, organize, coordinate, and execute assigned tasks.
  • Understanding the requirements of diverse stakeholders and conflict resolution management.
  • Delivery focused with the ability to exercise judgment, make decisions, and take action to complete assignments.
  • Able to work collaboratively.

In addition, you should exemplify our core values: Ambition, Ownership, Partnership, and Care.

  • Pv Partnership

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Role and FunctionAt 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 Icsr Manage

    vor 1 Woche

    Basel, Basel-Stadt, 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 & FunctionAt Sobi, we are...

  • Global Pv Partnership

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Role and FunctionAt 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...

  • International Pv Business Process Leader

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Our client, a leading pharmaceutical organization worldwide, is looking for aInternational Pharmacovigilance Business Process LeaderResponsibilities:- to involve an appropriate set of affiliates in global PV process design, development and maintenance.- to provide content contributions to PV process-related affiliate communication and training needs.-...

  • Global Pv Case Management Lead

    vor 1 Woche

    Basel, Basel-Stadt, 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 & FunctionAt Sobi, we are...

  • International Pv Business Process Leader

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Hobson Prior Vollzeit

    Hobson Prior are working alongside a brilliant biotech corporation who are currently looking for an individual to join their team on a contract basis. The opening position is for a Global PV Business Process Leader. Our client is focused on providing life-changing remedies for various illnesses.Please note that to be considered for this role you must have...

  • International Pv Business Process Leader

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    _The Life Science Career Network_International PV Business Process LeaderOur client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized...

  • Manager, Region Sales

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Power and Tel Vollzeit

    Role Purpose: Develop the executional & strategic path for the sales team within the assigned territory. Executive leadership of key accounts. Lead direction and productivity of district sales managers. Leading team to deliver new sales account acquisition Wireless, 3PL, Broadband & Telco & Enterprise markets. Business leader/voice for Power & Tel throughout...

  • Quality Assurance and Pharmacovigilance Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz ALTOGEN AG Vollzeit

    COMPANYALTOGEN 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 expert level...

  • Quality Assurance and Pharmacovigilance Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz ALTOGEN AG Vollzeit

    COMPANYALTOGEN 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 expert level...

  • Regional Marketing Manager Lac Region

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Recordati Group Vollzeit

    Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT , with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia...

  • Regulatory Affairs Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz ProClinical Vollzeit

    Salary:Highly CompetitiveJob type:PermanentDiscipline:Project ManagerLocation:Switzerland- Basel, Schweiz Posting date: 27 Feb 2024Reference:57992Proclinical are recruiting for a Regulatory Affairs Manager - EMEA to join a pharmaceutical organisation. This role is on a permanent basis and is located within the EMEA with the ability to either work remotely or...

  • HR Core Processes Lead for Gwm, Region Americas and

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz UBS Vollzeit

    Switzerland Zürich Human Resources (HR) Group FunctionsJob Reference #BRCity ZürichJob Type Full TimeYour role Do you want to play a key role in the drive to operational excellence? Are you able to handle multiple priorities (combination of new and repetitive) with energy and enthusiasm? Do you know how to juggle multiple projects effectively? We're...

  • Manager, Regulatory Affairs, International

    vor 1 Woche

    Basel, Basel-Stadt, 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.Manager, Regulatory Affairs,...

  • Key Account Manager Dach Region

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Brenntag Vollzeit

    KEY ACCOUNT MANAGER DACH REGION:Our team in Basel currently has an opening for a Key Account Manager DACH RegionYOUR ROLE & RESPONSIBILITIES: Support for key accounts in field sales and internal sales Utilisation of customer potential in terms of volumes, gross profit and other KPIs, development of new business (e.g. crossselling) Negotiating and closing...

  • Corporate Front Desk and Facilities Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Dufry International AG Vollzeit

    Dufry is the world's leading global Travel Experience Player, combining Travel Retail and Food & Beverage businesses to creating innovative and integrated offerings to travelers worldwide. Our 60,000 employees provide compelling offers and attractive services in approximately 5,500 outlets across more than 350 airports, seaports and other touristic locations...

  • Director, Qppv Compliance/quality Interface

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Moderna Vollzeit

    The RoleJoining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...

  • Emea Region Ehs&s Leader

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Axalta Coating Systems Vollzeit

    Job Description:Axalta has remained at the forefront of the coatings industry by continually investing in innovative solutions. We engineer technologies that protect customers' products - whether they are battling heat, light, corrosion, abrasion, moisture, or chemicals - and add dimension and beauty with colorful finishes. We have a vast and ever-evolving...

  • Global Product Manager Smilecloud

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Straumann Group Vollzeit

    Position SummaryThe Global Product Manager Smilecloud is responsible for commercialization of Straumann Smilecloud Solutions - a diverse portfolio comprising clinical software, patient-specific design ser-vices and integrated digital dentistry workflows. This position will play a key role in developing the next generation of Straumann digital services,...

  • Global Medical Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Bayer Vollzeit

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...