Philogen S.p.A. is a biotechnology company whose mission is the development of biologic products for the imaging and therapy of life-threatening diseases, with a special focus on angiogenesis related disorders.
Philogen S.p.A. would like to hire a Pharmacovigilance Associate. The role will report directly to the Responsible of Pharmacovigilance.
<strong>In particular the successful candidate will be responsible for:</strong>
<li>Collaboration in the assessment, triage and management of SAEs.</li>
<li>Collaboration in SUSAR submission (e.g.CIOMS-I form preparation).</li>
<li>Collaboration in the preparation and submission of the safety documents (e.g. DSUR and periodic safety reports) in accordance with applicable GCP requirements and legislation.</li>
<li>Preparation of the Communication and Notification to the Competent Authorities and Ethics Committees.</li>
<li>Assistant for the data coding using MedDRA dictionary.</li>
<li>Writing of Standard Operation Procedures (SOP) related to the Pharmacovigilance area.</li>
<li>Give support in preparation and in updating clinical documents including protocols, amendments, IB’s, interim and final safety reports to ensure regulatory compliance and safety throughout trial.</li>
<li>Maintenance and archiving of the paper Trial Master File in collaboration with the CTA.</li>
<li>Revision of clinical listings to clean safety data in collaboration with medical manager, CRA</li>
<li>and data manager.</li>
<strong>The ideal candidate should have:</strong>
<li>Previous experience in Pharmacovigilance activities or a Master degree in Pharmacovigilance.</li>
<li>Excellent written, verbal and organizational skills.</li>
<li>Strong prioritization skills.</li>
<li>Ability to handle multiple projects and stressful situations.</li>
<li>Good skills in data analysis.</li>
<li>Excellent scientific writing skills and fluency of the English language.</li>
A contract and salary proportional to the experience (seniority) of the successful candidate.
<strong>Job location: </strong>
Siena – Italy
Interested candidates are asked to send a detailed Curriculum Vitae, including the title of the position in the subject line, together with the authorization to process the personal data under the Legislative Decree 196/2003 to the e-mail address firstname.lastname@example.org.