Global Pharmacovigilance Safety Coordinator

2 giorni fa


Roma, Lazio, Italia Angelini Pharma A tempo pieno

We are seeking a skilled Pharmacovigilance Safety Reports Specialist 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.
  • Coordination: Ensure proper coordination of safety reports preparation, submission, and maintenance in a matrix organization, coordinating resources at HQ and Country level.
  • Document Review: Prepare and review pharmacovigilance and vigilance documents, including Periodic Safety Update Reports (PSURs), Risk Management Plan (RMP), and other safety-related documents.
  • Submission Compliance: Ensure safety reports submission compliance with Regulatory Authorities.
  • Response to Requests: Prepare and coordinate safety reports responses to supplementary requests, deficiency letters, or similar Regulatory Authorities' requests.
  • Data Collection: Collect and organize safety and applicable data requested by business partners for the preparation of safety reports.
  • Data Analysis: Analyze clinical and safety data to support the development of pharmacovigilance documents.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams, including local pharmacovigilance manager, medical experts, regulatory affairs, clinical teams, and business partners.
  • 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, Good Pharmacovigilance Practices (GVP), and EMA guidelines.

Requirements:

  • Education: Bachelor's or advanced degree in life sciences, pharmacy, biology, medicine, or a related field.
  • Experience: At least 5 years of successful experience in pharmacovigilance, specifically within safety reports management, gained in other pharmaceutical companies.
  • Regulatory Knowledge: In-depth knowledge and understanding of regulatory and pharmacovigilance guidelines and requirements.
  • Scientific Acumen: Proficiency in medical and scientific terminology, as well as the ability to critically analyze clinical and safety data.
  • Language Skills: Fluent in English.
  • Communication Skills: Excellent written and verbal communication skills to convey complex medical and scientific information.
  • Collaboration: Ability to work effectively in cross-functional teams and collaborate with subject matter experts.
  • Time Management: Effective time management skills to meet tight deadlines in a regulated environment.

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



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