PSMF & Compliance Manager

Chiesi Group; Italia; In loco; EUR 41.400 - 50.600; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Remote work options

Tax assistance for foreign colleagues

Descrizione del lavoro

Chiesi Group in Italy seeks a Pharmacovigilance professional to support GRAPS and ensure the PV system complies with regulatory requirements across global operations. The role emphasizes governance, PSMF updates, KPI definition, and periodic reporting of global PV status.

The candidate should hold a Master degree in life sciences or pharmacy with 5+ years in international PV, plus strong communication, decision-making and teamwork capabilities.

Competenze

• Master degree in life sciences, pharmacy or related field.
• Minimum 5 years of international Pharmacovigilance experience.
• Excellent communication and teamwork skills.

Mansioni

• Evaluate regulations, guidelines and recommendations for PV applicability worldwide.
• Ensure timely updates of the PSMF and advise the QPPV on changes.
• Define PV KPIs and propose improvements in monitoring, evaluation and reporting.
• Track metrics and compliance issues and their resolution.
• Deliver PSMF and KPI reports to stakeholders for global PV status assessment.

Conoscenze

Effective communication

Decision making

Judgement & problem solving

Team working

Formazione

Master Degree in life sciences, pharmacy or related fields

Descrizione del lavoro

This is what you will do

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.

Location

The position is based at our headquarters in Parma and offers a flexible hybrid working arrangement.

Compensation range

The 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.

Benefits

We offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more. In addition, we provide top‑class healthcare programs, work‑life balance initiatives, robust relocation support, flexible working arrangements, remote work options, tax assistance services for foreign colleagues, and other benefits designed to help you thrive.

Equal Opportunity Employer Statement

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.