Vaccine Pharmacovigilance Operations

vor 1 Woche

Zürich, Zürich, Schweiz Takeda Pharmaceutical Vollzeit

People First - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action.
Our people are the heart of Takeda.
This is an exciting time to join Takeda's Vaccine Business Unit, as we launch our global dengue vaccine.

You will have the opportunity to make a critical contribution to Global Vaccine Safety Evaluation (GVSE) team by supporting operational, strategic and cross-functional initiatives.


The Vaccine Pharmacovigilance Operations Project Manager will support to Takeda's Vaccine Pharmacovigilance (PV) department by providing oversight and direction for both clinical and post-marketing PV projects, as well as providing support for a broad variety of PV Operations activities.


PV Project Management:

  • Provide endtoend project management support to the Global Vaccine Safety Evaluation team.
  • For existing PV processes, partner with the project team to manage timelines, risks and stakeholders.
  • For PV related improvement activities, be responsible for the planning and maintenance of the project, helping the team adjust to changes in legislation, or working practices, as well as providing direct support.
  • Prepare meetings & supportive documentation with the aim to achieve clarity on issues for smooth project execution and efficient collaboration.
  • Maintain project plans, action lists, and prepare reports/presentations.
  • Manage and review proposals, vendor contracts and task orders, as required.
  • Represent GVSE in crossfunctional projects.

PV Operations Responsibilities:

  • Assist the PV Operations team in the assignment, tracking and production of key deliverables (reports, listings, mailbox management, database outputs).
  • Support in the preparation and review of PV SOPs / vendor material / Pharmacovigilance System Master File.
  • Manage compliance issues (CAPAs), audit & inspection findings and change control activities.
  • Provide support in audits and inspections for coordination and documentation.
  • Review of relevant PV documents in electronic archives/eTMFs to ensure consistency throughout the department.
  • Support in the preparation of PV meetings and presentations.

Desired Characteristics and Experience:

  • 2+ years experience working in global PV operations / PV CRO in both pre
- and post-marketing environments.

  • Education: life science degree (e.g., BSc, MSc or internationally recognized equivalent)
  • Previous project management experience or experience contributing to cross functional PV projects.
  • Excellence collaboration and interpersonal skills.
  • Strong analytical skills and the ability to manage multiple projects and to creatively resolve issues and mitigate risks.
  • Proactive and adaptable.
  • Knowledge of ICH GCP and GVP processes.

Empowering our people to shine

Diversity, Equity and Inclusion
Takeda is committed to foster diversity, equity and inclusion.

Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age or disability.


Locations:

Zurich, Switzerland

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

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