Global Pharmacovigilance Safety Coordinator
4 settimane fa
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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