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Life Scientist as Head of Country Pharmacovigilance (PV) (m/f)

 Bristol-Myers Squibb GmbH & Co. KGaA  Zug
We are currently seeking a talented Head of Country Pharmacovigilance to join our medical team in Switzerland. The Head of Country PV leads and brings to resolution with all appropriate functional groups, locally and globally, all product safety related issues that arise in the country and acts as the local PV representative on the crisis management team. Where applicable, leads and manages all local PV staff and ensures that they are competent, trained and developed effectively to perform their roles. Ensures audit readiness and leads cross-functional teams to ensure that internal and external inspections are conducted effectively and acts as back-up for the Austrian Head of Country PV. The Head of Country PV holds primary responsibility for all country pharmacovigilance and reports directly to the Hub Manager with a dotted line to the Country Medical Director (CMD).
BMS Behaviors required:
Passion: We pursue excellence to help patients prevail. I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect.
Innovation: We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes.
Accountability: We own our outcomes and the outcomes of others. I own BMS? Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them.
Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same
Job Function : Medical and Regulatory Affairs
Primary Location : EU-CH-ZG-Zug
Organization : Global Commercialization - Other

Head of Country Pharmacovigilance (PV) (Job Number: 1600869)

In order to enable success in the role, key areas of focus will include:
  • Collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases
  • Submission of single cases to local Health Agencies(HA) and Ethics Committees (EC)
  • Provision of safety information
  • Implementation of Pharmacovigilance Agreements
  • Maintenance of PV Awareness and Training
  • Ensure PV Audit and Inspection Readiness
  • Planning, processing and reporting of Aggregate Reports to HA and EC
  • Local Market Safety Data Quality Control
  • Risk management plans
  • Monitors and ensures adherence to local/regional/global regulatory requirements and relevant GPV&E procedures
  • Communicates with clarity and consistency to achieve alignment of stakeholder activities regarding safety risk related requirements internally and externally
  • Clearly articulates implications of changes. Contributes actively to the implementation of new legislation and GPV&E procedures/systems
  • Leads cross-functional teams for Risk Management and other safety related matters
  • Ensures PV compliance with relevant internal and external process/guidelines/regulations as well as appropriate management of LM PV Core Activities (AE reporting, aggregate report submission, training, audits/inspections, Risk Management processes and safety issues)
Key Stakeholders/Contacts:
  • VP International PV& QPPV Europe, Regional PV Director, Hub Manager
  • information/discussion/decision making/management support regarding local PV activities
  • Medical Information - Information/discussion regarding local PV activities
  • Local GRS- Information/discussion/decision making
  • International Risk Management group; GPV&E Global QST; GPV&E Global Assessment and Safety reporting group; GPVE MST; QP Office - Information/decision making regarding local PV activities
  • LM Business, Marketing & Sales force - information/discussion/decision regarding the local PV activities
  • Global Quality and Regulatory Compliance (GQRC) - information/discussion
  • HA/ECs - Discussion on matters related to the local PV activities
  • Contractual partners - Discussion on matters related to the local PV activities
  • University degree (preferably life science) or nursing qualification
  • At least 5 years’ experience in the Pharmaceutical Industry, with at least 2 years’ experience working in Pharmacovigilance or in a closely aligned field (e.g. Regulatory, Clinical, or Medical Information)
  • Demonstrated strong organizational, facilitation, interpersonal and communicating skills with cross functional teams locally
  • Subject matter expert in local, regional and any other relevant legislation with regard to PV, as well as BMS PV related process and systems
  • Utilizes effective decision making and a problem-solving approach to address safety issues, in a timely manner, while balancing the operation and strategic needs
  • Has a clear understanding of the broader impact and possible implications on processes/the environment and appropriately consults or escalates clearly articulated safety issues, while retaining accountability
  • Be highly proficient in German and English with the ability to work comfortably in French.
Bitte bewerben Sie Sich unter: www.b-ms.de/careers
Bitte beziehen Sie sich bei Ihrer Bewerbung auf jobvector und geben Sie die folgende Referenznummer an: 1600869

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