Senior Pharmacovigilance Project Manager

2 tygodni temu

Bydgoszcz, Polska Pharmiweb Pełny etat
Senior Pharmacovigilance Project Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Senior Pharmacovigilance Project Manager -

The role:

  • Ensures that Standard Operating Procedures (SOPs), policies and guidelines are adhered to at the project level. Ensure assignment of project specific training to project team.
  • Primary liaison for client and project team for project level (time, scope, cost, quality, resource) matters.
  • Manages & delivers assigned projects per fully executed contract, on schedule and on budget.
  • Leads and directs cross-functional team leads/managers and third parties/vendors with some supervision and support. Ensure team is familiar with client and project scope.
  • Responsible to develop and manage the Project Management Plan throughout the lifecycle of the project.
  • Contributes to development, maintenance and approval of project plans.
  • Guides and supports the project team-leads in prioritizing, trouble-shooting and contingency planning to ensure tasks are carried out in budget, on time and with quality by the project team.
  • Have an overview and understanding of all tasks and actions to be delivered and completed including deadlines and milestones, as applicable.
  • Leads and facilitates client and internal project meetings and responsible to approve meeting agenda and minutes. Ensure inclusion of applicable topics, actions and action item follow up.
  • Liaises with functional leads/managers to optimize performance and utilization and manages feedback of project team members.
  • Leads presentation of internal project status reviews (Pharmacovigilance Project Review or Finance Meetings) and is accountable for content development and action item follow up.
  • Proactively identifies, resolves/mitigates through ongoing review of project progress and metrics and escalates risks and/or issues until resolution.
  • Monitors compliance metrics (i.e. regulatory, training, project timelines) and project budgets to ensure regulations and timelines are being met and activities performed are within the approved budget.
  • Prepares project status report to client and ICON Pharmacovigilance Leadership.
  • Owns projections of units/hours (revenue and resources), actual units/hours efficiency analysis and invoice approvals.
  • Drives the on-time delivery of scope while actively managing change in scope requests and setting client and project team expectations.
  • Ensures that project team resource allocations are in line with budget and to achieve deliverables.
  • Proactively and timely identifies, negotiates and executes contract modifications for assigned projects.
  • Identifies potential or actual unrecoverable hours and provides analysis and mitigation/resolution plan for senior management’s approval.
  • Establishes project timelines for key milestones and deliverables and communicates project-specific priorities with the project team and monitors status for follow through.

.

What you need:

To be successful in the role, you will have:


  • Extensive experience in pharmacovigilance, particularly in safety reporting within a clinical trial setting.


  • Strong knowledge of global regulatory requirements for safety reporting (e.g., FDA, EMA, ICH guidelines).•


  • 5 years + experience in pharmacovigilance at a global level in a client facing role.


  • A degree in life sciences, pharmacy, or a related field; advanced degree preferred.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

  • Senior Project Manager Operations Lead

    1 dzień temu

    Bydgoszcz, Kujawsko-Pomorskie, Polska Heraeus Quarzglas GmbH & Co. KG (Heraeus Conamic) Pełny etat

    Senior Project Manager OperationsJoin Heraeus Conamic, a leading materials specialist, in a challenging role that requires strong leadership and project management skills. As a Senior Project Manager Operations, you will lead the construction and ramp of Heraeus' new Optics Production site, defining project scope, schedule, cost, resources, quality, and...

  • Senior Project Manager Operations

    1 miesiąc temu

    Bydgoszcz, Polska Heraeus Quarzglas GmbH & Co. KG (Heraeus Conamic) Pełny etat

    Senior Project Manager Operations (m/f/d) Location Bydgoszcz/ Hybrid Permanent Full Time (40 hours per week) . – . Zloty About Heraeus Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a family-owned global technology group, we combine materials expertise and technological...

  • Senior Project Manager Operations

    1 miesiąc temu

    Bydgoszcz, Polska Heraeus Quarzglas GmbH & Co. KG (Heraeus Conamic) Pełny etat

    Senior Project Manager Operations (m/f/d) Location BydgoszczPermanent Full Time About Heraeus Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a family-owned global technology group, we combine materials expertise and technological leadership to create the most diverse...

  • Project Manager

    1 miesiąc temu

    Bydgoszcz, Polska SCALO Sp. z o.o. Pełny etat

    Jesteśmy firmą technologiczną.Realizujemy projekty. Budujemy zespoły. Zapewniamy specjalistów do projektów.Za pomocą technologii wspieramy wzrost biznesowy naszych Klientów oraz tworzymy przestrzeń do ciągłego rozwoju naszego zespołu. Nasze Center of Excellence skupia najlepszych specjalistów SCALO, zajmujących się różnymi dziedzinami...

  • Technical Project Manager

    9 godzin temu

    Bydgoszcz, Polska SCALO Sp. z o.o. Pełny etat

    W Scalo zajmujemy się dostarczaniem projektów software"owych i wspieraniem naszych partnerów w rozwijaniu ich biznesu. Tworzymy oprogramowanie, które umożliwia ludziom dokonywanie zmian, działanie w szybszym tempie oraz osiąganie lepszych rezultatów. Jesteśmy firmą, która wykorzystuje szerokie spektrum usług IT, żeby pomagać klientom. Obszary...

  • Electrical project manager

    4 miesięcy temu

    Bydgoszcz, Polska LeasingTeam Group Pełny etat

    LeasingTeam Professional wspiera polskie i globalne przedsiębiorstwa w pozyskiwaniu kluczowych pracowników i zarządzaniu zasobami ludzkimi. Agencja specjalizuje się w rekrutacjach stałych na stanowiska średniego i wyższego szczebla oraz outsourcingu white-collar. Skutecznie realizuje zlecenia, pracując w oparciu o autorską metodologię ASSET®,...

  • Senior Project Manager

    4 tygodni temu

    Bydgoszcz, Polska Heraeus Pełny etat

    The following challenges await you: You lead the construction and ramp for new Heraeus' new Optics Production site. You define project scope, schedule, cost, resources, quality, and deliverables in collaboration with departments and stakeholders for site's capacity expansion. You develop full-scale project plans and associated communications...

  • IT Project Manager

    8 godzin temu

    Bydgoszcz, Polska Belma AS Sp. z o.o. Pełny etat

    BELMA ACCESSORIES SYSTEMS SP. Z O.O.Let's create together BAS to największy w regionie producent i eksporter wyrobów z blach. Obecnie zatrudniamy 1100 osób i jesteśmy jednym z największych pracodawców w województwie kujawsko – pomorskim.Podstawa naszego sukcesu leży w rękach naszych pracowników, dlatego dbamy o rozwój każdego z...

  • Project Manager

    2 tygodni temu

    Bydgoszcz, Polska PROJEKT-SOLARTECHNIK SPÓŁKA AKCYJNA Pełny etat

    Project Manager (farmy PV) Miejsce pracy: Bydgoszcz Twój zakres obowiązków koordynacja projektów farm fotowoltaicznych, również w fazie ich realizacji udział w przygotowaniu harmonogramu inwestycji, monitorowanie postępów realizacji, bieżąca kontrola inwestycji nadzór nad dokumentacją projektową oraz budżetem projektu organizacja pracy i...

  • Senior Agile Program Manager

    1 miesiąc temu

    Bydgoszcz, Polska SCALO Sp. z o.o. Pełny etat

    Jesteśmy firmą technologiczną.Realizujemy projekty. Budujemy zespoły. Zapewniamy specjalistów do projektów.Za pomocą technologii wspieramy wzrost biznesowy naszych Klientów oraz tworzymy przestrzeń do ciągłego rozwoju naszego zespołu. Nasze Center of Excellence skupia najlepszych specjalistów SCALO, zajmujących się różnymi dziedzinami...

  • IT Control Manager

    1 miesiąc temu

    Bydgoszcz, Polska LeasingTeam Group Pełny etat

    LeasingTeam Professional supports Polish and global enterprises in sourcing key talent and in human resources management. The Agency specializes in permanent recruitment for mid- and senior level positions and in white-collar outsourcing. It successfully completes recruitment projects by applying a trademark ASSET® methodology that structures recruiter...

  • IT Audit Manager

    2 miesięcy temu

    Bydgoszcz, Polska LeasingTeam Group Pełny etat

    LeasingTeam Professional supports Polish and global enterprises in sourcing key talent and in human resources management. The Agency specializes in permanent recruitment for mid- and senior level positions and in white-collar outsourcing. It successfully completes recruitment projects by applying a trademark ASSET® methodology that structures recruiter...

  • Finance Audit Manager

    2 miesięcy temu

    Bydgoszcz, Polska LeasingTeam Group Pełny etat

    LeasingTeam Professional supports Polish and global enterprises in sourcing key talent and in human resources management. The Agency specializes in permanent recruitment for mid- and senior level positions and in white-collar outsourcing. It successfully completes recruitment projects by applying a trademark ASSET® methodology that structures recruiter...

  • Internal Control Manager

    4 tygodni temu

    Bydgoszcz, Polska LeasingTeam Group Pełny etat

    LeasingTeam Professional supports Polish and global enterprises in sourcing key talent and in human resources management. The Agency specializes in permanent recruitment for mid- and senior level positions and in white-collar outsourcing. It successfully completes recruitment projects by applying a trademark ASSET® methodology that structures recruiter...

  • Finance & IT Controls Manager

    2 miesięcy temu

    Bydgoszcz, Polska LeasingTeam Group Pełny etat

    LeasingTeam Professional supports Polish and global enterprises in sourcing key talent and in human resources management. The Agency specializes in permanent recruitment for mid- and senior level positions and in white-collar outsourcing. It successfully completes recruitment projects by applying a trademark ASSET® methodology that structures recruiter...

  • Audit Manager

    2 miesięcy temu

    Bydgoszcz, Polska LeasingTeam Group Pełny etat

    LeasingTeam Professional supports Polish and global enterprises in sourcing key talent and in human resources management. The Agency specializes in permanent recruitment for mid- and senior level positions and in white-collar outsourcing. It successfully completes recruitment projects by applying a trademark ASSET® methodology that structures recruiter...

  • Senior Java Software Engineer

    1 dzień temu

    Bydgoszcz, Kujawsko-Pomorskie, Polska softbluesa Pełny etat

    Senior Java Software DeveloperWe are seeking a highly skilled Senior Java Software Developer to join our team at SoftBlue SA. As a key member of our development team, you will play a crucial role in designing and implementing innovative solutions for our international customers.About the Role:Design and develop high-quality software solutions using Java 8/11...

  • Senior Software Buyer

    2 miesięcy temu

    Bydgoszcz, Polska Atos Poland Global Services Sp. z o.o. Pełny etat

    about-project : Join our NE Procurement Department and become a senior software buyer. The role is strategically meaningful to the successful delivery of required cost case for our business. It requires cross functional working with many different areas of the NE business including all Service Lines, Major Accounts and Verticals. As a Senior software buyer...

  • Senior Product Marketing Manager

    4 miesięcy temu

    Bydgoszcz, Polska Huuuge Games Pełny etat

    Senior Product Marketing ManagerYour responsibilities Innovative Marketing: implement unique marketing strategies that stand out and capture the audience's attention Organic vs. Marketing Initiatives: manage a blend of organic and paid marketing campaigns, such as...

  • Senior Cybersecurity Software Engineer

    1 dzień temu

    Bydgoszcz, Kujawsko-Pomorskie, Polska Avenga Pełny etat

    About the RoleWe are seeking a highly skilled Senior Software Developer Cybersecurity to join our team at Avenga. As a key member of our multidisciplinary team, you will be responsible for leading software development, deployment, integration, and testing activities.Key ResponsibilitiesDevelop and implement innovative software solutions to address complex...