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.
Pharmacovigilance Associate
Philogen S.p.A. would like to hire a Pharmacovigilance Associate. The role will report directly to the Responsible of Pharmacovigilance.
In particular the successful candidate will be responsible for:
- Collaboration in the assessment, triage and management of SAEs.
- Collaboration in SUSAR submission (e.g.CIOMS-I form preparation).
- 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.
- Preparation of the Communication and Notification to the Competent Authorities and Ethics Committees.
- Assistant for the data coding using MedDRA dictionary.
- Writing of Standard Operation Procedures (SOP) related to the Pharmacovigilance area.
- 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.
- Maintenance and archiving of the paper Trial Master File in collaboration with the CTA.
- Revision of clinical listings to clean safety data in collaboration with medical manager, CRA
- and data manager.
The ideal candidate should have:
- Previous experience in Pharmacovigilance activities or a Master degree in Pharmacovigilance.
- Excellent written, verbal and organizational skills.
- Strong prioritization skills.
- Ability to handle multiple projects and stressful situations.
- Good skills in data analysis.
- Excellent scientific writing skills and fluency of the English language.
We offer:
A contract and salary proportional to the experience (seniority) of the successful candidate.
Job location:
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 jobopportunities@philogen.it.