Global Pharmacovigilance Safety Coordinator

4 settimane fa


Roma, Lazio, Italia Angelini Pharma A tempo pieno

We are seeking a skilled Global Pharmacovigilance Safety Coordinator to join our team at Angelini Pharma.

Main Responsibilities:

  • Document Preparation:
    • Schedule and maintain the planning of all safety reports for medicinal products and medical devices across different geographies where Angelini is present.
    • Ensure proper coordination of safety reports preparation, submission, and maintenance in a matrix organization.
    • Prepare and review pharmacovigilance and vigilance documents, including PSURs, RMPs, DSURs, and other safety-related documents.
    • Prepare eCTD submissions for PSURs.
    • Ensure safety reports submission compliance with regulatory authorities.
    • Prepare and coordinate safety reports responses to supplementary requests and deficiency letters.
      • Collect and organize safety and applicable data requested by business partners for safety reports preparation.
    • Data Analysis:
      • Analyse clinical and safety data to support pharmacovigilance document development, including adverse event evaluation and safety signal analysis.
    • Collaboration:
      • Collaborate with cross-functional teams, including pharmacovigilance managers, medical experts, regulatory affairs, and clinical teams.
    • Quality Control:
      • Conduct quality control checks to ensure accuracy, consistency, and completeness of documents.
    • Regulatory Compliance:
      • Ensure all documents adhere to regulatory guidelines, including ICH guidelines, GVP, and EMA guidelines.

Requirements:

  • Bachelor's or advanced degree in life sciences, pharmacy, biology, medicine, or a related field.
  • At least 5 years of experience in pharmacovigilance, specifically in safety reports management.
  • In-depth knowledge of regulatory and pharmacovigilance guidelines and requirements.
  • Scientific acumen, proficiency in medical and scientific terminology, and ability to critically analyse clinical and safety data.
  • Fluent in English.
  • Excellent written and verbal communication skills.
  • Ability to work effectively in cross-functional teams and collaborate with subject matter experts.
  • Effective time management skills to meet tight deadlines in a regulated environment.

We offer a permanent contract and a chance to work in a diverse and inclusive environment at Angelini Pharma.



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