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Senior Specialist, Regulatory & PV Network

🕒 10 days ago
PharmacovigilanceRegulatory StrategyProject ManagementICH GCP

📜 Description

  • Act as Local Contact Person for Pharmacovigilance for the designated country
  • Lead projects of medium/high complexity, ensuring effective coordination and management of regulatory deliverables
  • Develop strategy and manage setup activities including project management plans and core documents
  • Provide strategic input to customers and address potential risks with preventive measures
  • Monitor project budgets and ensure compliance with training assignments
  • Foster professional relationships with internal and external contacts for efficient service delivery

🛠️ Requirements

  • Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience
  • Strong experience within pharmaceutical or CRO industry or regulatory body
  • Good knowledge of ICH GCP and/or GVP and national regulations
  • PV training and/or relevant working experience
  • Fluent in English and the official language of the country
  • Good planning and organizational skills
  • Strong interpersonal skills in a fast-paced environment
  • Attention to detail

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