Global Pharmacovigilance Safety Coordinator
3 settimane fa
Global Pharmacovigilance Safety Coordinator Opportunity
Main Activities- Document Preparation: Schedule and maintenance of 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/maintenance working in a matrix organization (indirect coordination of resources at HQ and Country level).
- Prepare and review pharmacovigilance and vigilance documents, including Periodic Safety Update Reports (PSURs), Risk Management Plan (RMP), Addendum to the Clinical Overview (RMP), DSUR (Development Safety Update Report), Post Marketing Surveillance Plan (PSMP), and other ad-hoc safety-related documents.
- Prepare the eCTD for the submission of the PSURs.
- Ensure safety reports submission compliance reporting to the Regulatory Authorities.
- Prepare and coordinate safety reports responses to supplementary requests, deficiency letters, or similar Regulatory Authorities’ requests received through the document assessment procedures.
- Collect and organize any safety and applicable data requested by business partners for the preparation of safety reports, as per the applicable PV agreement.
- Bachelor’s or advanced degree in life sciences, pharmacy, biology, medicine, or a related field.
- At least 5 years of successful experience in the pharmacovigilance field, specifically within safety reports management, gained in other pharmaceutical companies.
- 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 analyse clinical and safety data.
- Fluent in English.
- Communication Skills: Excellent written and verbal communication skills, as need to convey complex medical and scientific information clearly.
- 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.
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Roma, Lazio, Italia Angelini Pharma A tempo pienoJob Title: Global Pharmacovigilance Safety CoordinatorWe are seeking a highly skilled Global Pharmacovigilance Safety Coordinator to join our team at Angelini Pharma. As a key member of our pharmacovigilance team, you will play a critical role in ensuring the safety of our medicinal products and medical devices.Main Responsibilities:Document Preparation:...
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Global Pharmacovigilance Safety Coordinator
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Roma, Lazio, Italia Angelini Pharma A tempo pienoWe 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,...
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Global Pharmacovigilance Safety Coordinator
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Roma, Lazio, Italia Angelini Pharma A tempo pienoWe 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...
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Roma, Lazio, Italia Angelini Pharma A tempo pienoJob SummaryWe are seeking a highly skilled Pharmacovigilance Safety Specialist to join our team at Angelini Pharma. The successful candidate will be responsible for coordinating the preparation and submission of safety reports for medicinal products and medical devices across various geographies.Main ResponsibilitiesDocument Preparation: Schedule and...
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