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Alexion Pharmaceuticals Associate Director, Patient Safety
Munich
Neu Veröffentlicht am 21.10.2024 Festanstellung
Associate Director, Patient Safety

This is what you will do:

This position has primary responsibility for ensuring oversight of the global case processing vendor who is engaged in the collection, follow-up, onward transmission of domestic cases within Alexion Germany and shall take care that those processes are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any PV agreements with third party business partners.

Within the assigned geographic area, the Associate Director, Patient Safety is responsible for appropriate local PV system oversight, including any elements of the PV system that are contracted to a third party. This includes responsibility for ensuring the processes and systems necessary for the Associate Director, Patient Safety to fulfil their responsibilities, both internal and outsourced, comply with global and local requirements: remain current with applicable regulations: and are followed consistently, by ensuring delivery of any training necessary. The Associate Director, Patient Safety tracks system performance including regulatory compliance and provides periodic reports to management.

The Associate Director, Patient Safety reports into the Cluster Lead Alpine AstraZeneca.

You will be responsible for:

  • Oversight of case processing vendor who is engaged in the collection, translation, entering of initial/follow-up AE information into the safety database including follow-up activities, as appropriate, that originates from any relevant PV data source, and onward forwarding of the AE information to vendor if received locally.
  • Oversight of Literature Screening activities by global vendor and annual review of journals
  • Regulatory Intelligence
  • PV routes testing
  • Reconciliation activities as applicable
  • Digital Assets review and oversight
  • Oversight of PV-relevant third-party vendors including developing and maintaining effective business relationships and tracking performance metrics including regulatory compliance
  • Act as primary contact for Global Patient Safety and local staff in the countries of responsibility when needed
  • Executes CAPA plans and oversees the development implementation as needed
  • Provision of PV expertise, review and safety approval to Organized Data Collection activities such as Market Research Programs, Patient Support Programs, non-interventional studies incl. oversight of the vendors and review of contracts
  • Tracking of performance including regulatory compliance and provision of periodic metric reports to General management and Global Safety
  • Review and approval of late cases reported late to GPS
  • Provide PV-training to local country staff and related contractors/vendors as applicable
  • Local PV system oversight including any elements of the PV system that are contracted to a third party, ensuring inspection-readiness at all times.
  • Local aRMM implementation, relevant associated documents and metrics maintenance and lead of the Local aRMM implementation team in the country as applicable
  • Represents GPS during local Pharmacovigilance audits and inspections
  • Other PV related tasks may be requested on demand
  • Qualifications

  • University degree in medicine, pharmacy, natural sciences
  • Extensive experience in pharmaceutical industry or equivalent with majority in a PV functional role (minimum 4 years)
  • Fluent in German and English language required
  • The candidate should be a self-starter, with a desire to be part of an open and collaborative team.
  • The candidate should demonstrate ability to quickly assimilate new information and translate into actionable strategies and activities
  • Ability to manage multiple projects simultaneously and well-developed prioritization skills are strong asset
  • Ability to build team relationship and collaborate in a global team environment at all level of the organization
  • Strong interpersonal communication
  • Understand the origin and reasoning behind key policies, practices and procedures
  • Can anticipate challenges and take timely and pro-active action
  • Date Posted

    21-Okt.-2024

    Closing Date

    29-Nov.-2024

    Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

    Standort

    Alexion Pharmaceuticals, Munich

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