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ABAbbVie

Affiliate Safety Representative (ASR)(m/w/x)

Cham
Full-timeWith Home OfficeExperienced
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Independent pharmacovigilance management and Swiss regulatory alignment for a global biopharmaceutical manufacturer. Two years of pharmaceutical PV experience and life-sciences degree required. Direct report management, reporting to Medical Director.

Requirements

  • Medical, pharmacy, life-sciences degree or equivalent
  • Two years' pharmaceutical pharmacovigilance experience
  • Scientific acumen and conceptual application skills
  • Knowledge of PV activities and systems
  • Understanding of Swiss regulatory PV requirements
  • Excellent communication and presentation skills
  • Fluency in English and German
  • French language skills (advantageous)
  • High customer orientation
  • Commitment to compliance and quality
  • Sound judgment and organizational skills
  • Strong sense of urgency

Tasks

  • Report to the Medical Director
  • Manage one direct report
  • Drive local pharmacovigilance activities independently
  • Align affiliate procedures with corporate regulations
  • Manage non-conformities and exception processes
  • Execute corrective and preventive actions
  • Oversee the affiliate PV training plan
  • Ensure training compliance for partner staff
  • Maintain the adverse event intake system
  • Process and translate safety information
  • Reconcile spontaneous and solicited safety data
  • Partner with Regional PV Teams
  • Report individual case safety reports
  • Submit periodic and aggregate safety reports
  • Develop local safety and PV strategies
  • Advise cross-functional partners on safety topics
  • Monitor and assess local safety intelligence
  • Lead affiliate PV audits and inspections
  • Implement safety data exchange agreements
  • Identify all local adverse event sources
  • Maintain the PV Agreements Database inventory
  • Develop specialized PV training materials
  • Lead local risk management activities
  • Coordinate risk minimization measure distribution
  • Monitor medicinal product safety profiles
  • Track post-authorization safety study commitments
  • Generate and interpret safety evidence
  • Communicate safety concerns to Global Teams
  • Share safety insights with Medical Teams
  • Lead product safety education initiatives
  • Assess impact of new PV legislation
  • Drive internal and external advocacy efforts
  • Engage with local regulatory agencies

Work Experience

2 years

Education

Bachelor's degree

Languages

English – Business FluentGerman – Business FluentFrench – Basic

Tools & Technologies

PV systems
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