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Air Medicinal Product Safety Manager

1 settimana fa

Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.p.A. A tempo pieno

About the Role

We are seeking a highly skilled and experienced Pharmacovigilance Specialist/Manager Air Expert to join our Global PV Operations team. The successful candidate will have a strong background in Pharmacovigilance, with at least 3 years of experience within Pharmaceutical and/or Biotechnology industry, including at least 1 year of experience in Post-Market safety.

The ideal candidate will have a Master degree in science, medicine, biology, pharmacy or related fields, with addition background in Pharmacovigilance being considered as a plus. He/she will have excellent analytical skills, attention to detail, and strong communication skills.

The role involves collaborating with Global PV Operations Unit Head, Specialists and Managers in specific projects within the assigned Business Area, providing input within the GPV specific Business Unit. The successful candidate will be responsible for managing clinical trials, organized data collections, and Compassionate use/expanded access programs, including non-interventional studies (Post-Authorisation Safety Studies [PASSs] included).

Responsibilities
  1. Collaborate with Global PV Operations Unit Head, Specialists and Managers in specific projects within the assigned Business Area
  2. Provide input within the GPV specific Business Unit
  3. Manage clinical trials, organized data collections, and Compassionate use/expanded access programs, including non-interventional studies (Post-Authorisation Safety Studies [PASSs] included)
  4. Oversight/review adverse event reports for investigational medicinal products or marketed drugs, ensuring compliance with regulatory guidelines and completeness of documentation
  5. Monitor PV operations activities of CROs involved in studies
  6. Perform Quality Control activities
  7. Provide inputs on global SOPs and WIs and other controlled documents
  8. Support other PV activities, both at global and affiliate level
  9. Be responsible for cross-functional projects and processes
  10. Participate in audit and inspection activities
  11. Maintain compliance to relevant regulations, policies and procedures
  12. Participate to the Departmental meetings and project-specific teams
  13. Represent GPV department in cross-functional corporate teams and projects