Regulatory Compliance Specialist
3 settimane fa
About the Role
">Ipsen Spa, a dynamic and growing global specialty-driven biopharmaceutical company, is seeking a highly skilled Regulatory Compliance Specialist to join our team. With a strong focus on innovation and specialty care, Ipsen aims to make a sustainable difference by improving patients' health and quality of life.
As a Regulatory Compliance Specialist, you will be accountable for ensuring compliance with local regulations and Company procedures in Pharmacovigilance. This role requires a high standard of quality and contribution to the improvement of the local Pharmacovigilance system.
Main Responsibilities:
">- ">
- Ensure the collection of Adverse Events from every source, follow-up activity, and transmission to Global Pharmacovigilance System are managed in compliance with local regulations and company policies/procedures at local and global level.">
- Ensure reconciliations with local internal interfaces who shall receive potential AE (Medical Information, Patient Centric Services), with GPS and with external stakeholders.">
- Oversee Local Literature screening process conducted by Global PV Vendor.">
- Ensure local regulatory intelligence; assesses and oversees implementation of updated local PV regulatory requirements to the local PV system.">
- Maintain local source document in accordance with applicable record retention requirements.">
- Perform root cause analysis of deviation relevant to the local PV processes.">
- Support Drug Safety Lead in managing PDCS (Market Research Program/Patient Support Program/Early Access Program) and processes and tool in place for the correct governance of the PV requirements.">
- Support DSL in maintaining the PV Quality Management System (SOPs, KPIs, metrics, local gap analysis vs the global Quality Documents).">
- Creation, review, maintenance of PV training materials for internal and external stakeholders.">
- Support DSL in Vendor Management & oversight (Including back-up service provider).">
- Participates to periodic Meeting with GPS and collaborate with DSL in the management of reports for GPS.">
Requirements:
">- ">
- 1+ year of experience in Pharmacovigilance.">
- Master's degree in science, medicine, biology, pharmacy or related fields;">
- Background in Pharmacovigilance.">
- Fluent Italian">
- Fluent English">
- Up-to-date knowledge of PV post-market regulations (e.g. Good Pharmacovigilance Practices)">
- IT Skills: Microsoft Office Package; safety database and other data management systems">
- Attention to Details
Problem solving
Activities planning
Team working
Quality orientation">
Estimated Salary: € 45,000 - € 55,000 per annum depending on experience.
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