PSMF & Compliance Manager

13 ago - Italia
Chiesi Group

This is what you will do Se pensa di essere il profilo ideale per la seguente occasione, si candidi dopo aver letto la descrizione completa.To support GRAPS in ensuring that Company's pharmacovigilance system is consistent with the regulatory requirements in terms of structure and performances.
You will be responsible for
- Evaluate relevant pharmacovigilance regulations, guidelines and recommendations for their applicability to the Company's PV system and support all concerned functions worldwide in the implementation in their areas.
- Ensure that the PSMF is timely and properly updated by collecting all the requested documents from concerned stakeholders, and advise the QPPV and other stakeholders on potential changes and amendments.
- Contribute in the definition of pharmacovigilance KPIs and propose improvements in monitoring, evaluation and reporting to increase the efficiency of the PV system.
- Track metrics and trends as well as compliance issues and their resolution on a periodic basis.




- Deliver reports related to the PSMF and KPIs to concerned stakeholders for evaluation of the Global PV system status and performance.

You will need to have
- Master Degree in life sciences, pharmacy or related fields.
- Minimum 5 years of experience in international Pharmacovigilance within Pharmaceutical and/or Biotechnology industry and/or Contract Research Organisation.
- Effective Communication.
- Decision Making.
- Effective judgement and problem solving.
- Team working.

LocationThe position is based at our headquarters in Parma and offers a flexible hybrid working arrangement.
Compensation rangeThe minimum salary for this role is €46,000, aligned to our established salary framework. The final offer will reflect the candidate's skills, experience, qualifications and internal equity considerations.
This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.
BenefitsWe offer a comprehensive benefits package includin

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