PSMF Compliance Manager
takeda
Brussels, Belgium
3 dagen geleden

Objectives

Work closely with Takeda PSMF expert, provide back-up for PSMF expert and being part of Takeda EU QPPV office meeting objectives for GPSE.

Maintenance, development, production and distribution of the Takeda Pharmacovigilance System Master File (PSMF), including non-European versions (as required).

Monitor performance / compliance, training, the conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and EU GVP.

Ensure the company meets its legal obligation pertaining to EU regulation for the monitoring of the products with a marketing authorization in the EEA through working with the groups involved with Global Compliance and Standards, Global Regulatory Affairs, Quality Assurance and the LOC management function.

Ensures success of integration activities for the Takeda PV systems.

Under leadership of EUQPPV, coordinate building up an international QPPV network for the company and working alongside PV Affiliate Relations function.

Responsibilities

Participate in integration activities for the EUQPPV office, working closely and as back-up for PSMF expert.

Supporting the integration of PSMFs for Takeda.

Evaluate and monitor internal / external compliance metrics.

Alert management, including EUQPPV, of significant deficiencies in quality or compliance standards including proposed corrective / preventative actions.

Ensures Pharmacovigilance compliance based on expectations and / or requirements of regulatory agencies, internal processes, and external business partner obligations.

Helps maintain PSMFs. Interacts with contributing functions to improve and enhance the final output of PSMF. Ensure the PSMF compliance with regulations including readiness to submit within required timelines.

Supports EUQPPV responses and corrective and preventative action plans (CAPAs) to audit / inspection findings for adequacy and timeliness, reviews implementation, and supports the close out of all corrective and preventative actions.

Support business partner audits and QA audits of business partners relevant to EUQPPV.

Provides support prior to, during and after regulatory inspections in EEA.

Work with Key internal and external stakeholders to define and ensure compliance with global business and regulatory requirements.

Work with PSMF expert on responsibility for PSMF procedural documents and participate / support in the revision and / or authoring process of other key procedural documents as required.

Other tasks as assigned.

Supports building up and international QPPV network for Takeda in conjuction with other sub-functions of GPSE

Education and Experience Requirements

  • The position requires a minimum of a Bachelor’s degree in Pharmacy, Biology, Nursing, Toxicology, Medicine or an equivalent degree from the Life Science field.
  • Strong work ethic and the capacity to work in a fast-paced environment; flexible and quickly adaptable to changing priorities
  • Five years of professional experience with Pharmacovigilance or similar safety and risk evaluating work experience from industry, authority or academia.
  • Knowledge of global PV regulations especially for EU
  • Experience in noncompliance investigation, CAPA development, and audits preferred
  • Key Skills, Abilities, and Competencies

  • Strong attention to detail, establishing priorities, scheduling and meeting deadlines
  • Proven ability to work independently, take initiative, and complete tasks to meet deadlines
  • Strong negotiations skills including proved solution finding ability
  • Good communication, presentation, and interpersonal skills
  • Excellent problem solving skills and attention to detail
  • Demonstrate a can-do attitude
  • Complexity and Problem Solving

  • The incumbent will need to synthesize information from multiple sources in order to create priorities relative to corrective / preventative measures to maintain and improve compliance;
  • understand when procedural initiation and updates are required; and maintain training programs that ensure compliance with global standards.

    Internal and External Contacts

    Internal Contacts include : GPSE Organization, EU QPPV and other QPPVs as required by law; Quality Assurance, Regulatory Affairs, R&D compliance personnel,

    External Contacts include : Vendors, Distributors, Regulatory authorities as required

    Other Job Requirements

    May require travel both domestically and internationally.

    PHYSICAL DEMANDS :

  • Routine demands of an office based environment.
  • TRAVEL REQUIREMENTS :

  • Estimated 0-3 times per year, including possible international travel.
  • Full time

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