Patient Safety Specialist Nordics

at  Sandoz

København, Region Hovedstaden, Denmark -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate11 Aug, 2024Not Specified11 May, 20242 year(s) or abovePv,Pharmacovigilance,Databases,Pharmaceutical Industry,Organizational Development,TrainingNoNo
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Description:

ESSENTIAL REQUIREMENTS:

  • Minimum 2-3 years’ experience in drug-safety or pharmacovigilance (preferred) and experience in pharmaceutical industry.
  • Demonstrated leadership and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry Strong understanding of the factors which drive organizational development and change.
  • Knowledge of regional and local requirements relating to PV. Ability to solve complex regulatory issues and requirements.
  • Working knowledge of PV-processes, covering compliance, databases, procedures, QA, training. Proven ability to critically evaluate and integrate data from a broad range of areas/domains. Ability to effectively communicate with different stakeholders.
  • Fluent local language (Danish) skills and at least intermediate English languages skills (both written and spoken), additional language capabilities e.g. Swedish are an asset.
  • Computer/IT systems literacy.

Responsibilities:

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but not limited to:

  • In the context of the Sandoz Pharmacovigilance System, patient safety operating model, and associated quality system, ensure that local safety procedures are comprehensive, effective, compliant, and well embedded in the cross-functional and global-regional-local environment.
  • Promote a thorough understanding of the pharmacovigilance system, adherence to safety requirements for local activities.
  • Ensure the seamless flow of safety relevant information, within the affiliate, with local business partners and with regional hubs and 3rd party vendor in accordance with the Sandoz patient safety operating model.
  • Provide safety expertise and support for all marketed and investigational products - drugs and combination products - to other functions in the affiliate.
  • Participate in the maintenance of the local quality management system, including training, records management, regulatory intelligence, audit and inspection readiness, in collaboration with local, regional and global functions, business partners and vendors.

Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.

  • Competitive salary and Bonus based on personal and company results
  • Pension Scheme
  • Health Insurance
  • Flexible working conditions with hybrid working policy
  • Employee recognition scheme
  • Development both professionally and personally
  • Learning about company processe


REQUIREMENT SUMMARY

Min:2.0Max:3.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

København, Denmark