Wwps Gso Pv System Excellence - Boudry, Schweiz - Bristol Myers Squibb

Bristol Myers Squibb
Bristol Myers Squibb
Geprüftes Unternehmen
Boudry, Schweiz

vor 1 Monat

Lena Schneider

Geschrieben von:

Lena Schneider

beBee Recruiter
Beschreibung

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.

From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.

Take your career farther than you thought possible.


The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

The WWPS GSO PV System Excellence & QPPV support Manager role will support the organization by:

  • Coordinate submissions of the CAP Periodic Benefit-Risk Evaluation Reports (PBRERs/PSURs) within the European Economic Area (EEA)QPPV
  • Collaborate to internal dissemination of signals, PRAC recommendations, advanced notification, PBRER assessment reports for established brand to relevant stakeholders
  • Support coordination and submission requirements for Safety Aggregate Reports (SARs) in the EU (as applicable)
  • PV Intelligence: administrative support for the maintenance of the local market summary legislation sheets
  • Collaborate to projects involving WWPS organization for continuous improvements
  • QPPV analytics data generation support

RESPONSIBILITIES

  • Liaise on matters related to (CAP) PSUR preparation and communication
  • Coordination role of CAP PSUR submissions as necessary (GSM/BP/HQ/LM)
  • Distribution of the IMPD information (Investigational Medicinal Product Dossier) to PV personnel of the concerned EEA Local Markets
  • Support coordination of:
  • MRP and NAP PSUR/PBRERs in liaison with vendor as applicable
  • Planning responsibilities for EU Reference Date List update
  • PRAC recommendations for established brand products
  • Responses to the EMA (PSUR Repository) regarding assessment reports for established brand PSURs/PBRERs and liaison with vendor as applicable
  • PV intelligence related activities administrative support for accuracy of local market summary legislation sheets tracking purposes
  • Partner with WWPS and external WWPS stakeholders to proactively identify opportunities for process improvement to increase the effectiveness and efficiency of the Worldwide Patient Safety organization e.g., on SAR submission
  • Collaborate to the generation of Analytics data for QPPV oversight: i.e. PSMF Metrics & KPIs, Safety Variations, QPPV Notifications
(Disclaimer:
The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)


QUALIFICATIONS

  • Minimum 5 years' experience in pharmaceutical industry with at least 3 years PV exposure
  • Scientific Degree

SOFT SKILLS REQUIREMENTS

  • Critical thinking
  • Decision making
  • Teamwork
  • Organizational and followup skills
  • Time management and prioritizing skills
  • Change Management
  • Ability to manage multiple tasks and utilize effective problemsolving approaches and follows up and resolves outstanding issues
  • Working in an international environment
  • Communicates with clarity and consistency to achieve alignment of stakeholder activities regarding safety risk related requirements internally (local/regional/HQ) and externally (HAs, BPs).
  • Microsoft Suite, including MS Project
  • Other systems as needed

Uniquely Interesting Work, Life-changing Careers

On-site Protocol

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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