Pharmacovigilance Officer

1 settimana fa

Milano, Lombardia, Italia Ipsen SpA A tempo pieno

Pharmacovigilance Officer - Fix-Term Contract (Maternity Cover)
Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.


We aim to make a sustainable difference by significantly
improving patients' health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in
oncology, neurosciences, and rare diseases.


Ipsen also benefits from a rich heritage in primary care and a healthy portfolio in its growing Consumer Healthcare global business unit with outstanding products in gastroenterology and neurodegenerative diseases.


The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people's lives.


We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.


The
Pharmacovigilance Officer will be accountable for the conduction of routine local PV activities in compliance with local regulations and Company procedures, ensuring high standard of quality and contributing to the improvement of the local Pharmacovigilance system.


Main Responsibilities:

  • Ensure that the collection of AEs from every source, follow up activity, and transmission to GPS 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 ( med info, PCS), 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 backup service provider)
  • Participates to periodic Meeting with GPS and collaborate with DSL in the management of reports for GPS

Experience Required
1+ year of experience in Pharmacovigilance

Education
Master's degree in science, medicine, biology, pharmacy or related fields;
Background in Pharmacovigilance

Languages
Fluent Italian

Fluent English

Technical Skills
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

Soft Skills
Attention to Details

Problem solving

Activities planning

Team working

Quality orientation

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