Manager, Patient Safety

Iqvia Italia; Bardi; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A global pharmaceutical company is seeking a Manager, Patient Safety in Bardi, Italy. The role involves integrating local insights into decision-making, managing regulatory compliance, and providing local safety expertise. The ideal candidate should have confirmed experience in pharmacovigilance and excellent communication skills, along with a comprehensive understanding of drug safety regulations. A Chemical Contract with a starting duration of 1 year is offered.

Competenze

• Confirmed practical experience in pharmacovigilance.
• Ability to work with a high degree of autonomy.
• Comprehensive understanding of drug safety regulations.
• Excellent communication skills.

Mansioni

• Integrate local insights into decision-making and benefit/risk management.
• Act as the local subject matter expert for product safety.
• Manage internal PV audits and regulatory inspections.
• Develop and update local Risk Management Plans.
• Lead local communication of safety information to authorities.

Conoscenze

Pharmacovigilance experience

Autonomy

Understanding of drug safety regulations

Leadership or influencing skills

Communication skills

Fluent English

Descrizione del lavoro

Overview

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a Manager, Patient Safety who can join an exciting working environment in a dynamic atmosphere areas.

Responsibilities

Patient Centricity & Strategic Partnership

• Integrate local insights into decision-making and benefit/risk management.
• Collaborate with global and local teams to implement safe, compliant solutions for patient programs and commercial projects.

Local Studies & Research

• Provide strategic input on post-marketing surveillance, post-approval studies, Investigator Sponsored Research (ISRs), and early access programs.
• Oversight of local solicited programs and studies.

Local Safety Expertise

• Act as the local subject matter expert for product safety.
• Monitor safety profiles and emerging concerns for marketed products.

Compliance & Audits

• Manage internal PV audits and regulatory inspections.
• Ensure adherence to local regulations and company standards.

Risk Management

• Develop and update local Risk Management Plans (RMPs) and country-specific annexes.
• Oversee risk minimization activities and materials.

Regulatory Intelligence

• Maintain expert knowledge of local PV regulations.
• Communicate regulatory changes and participate in industry forums.

Safety Communication & Reporting

• Lead local communication of safety information to authorities and stakeholders.
• Ensure timely submission of PSURs, signals, RMPs, PMS, and responses to health authorities.

Business Integration & Leadership

• Act as Patient Safety ambassador within the affiliate leadership team.
• Build strong business relationships to support PV strategy and forecasting.

Quality Management & Training

• Maintain local PV quality systems and procedures.
• Deliver engaging training on safety reporting and compliance.

Case Management & Data Oversight

• Ensure timely processing and submission of Individual Case Safety Reports (ICSRs).
• Manage local literature monitoring and data checks for compliance.

Legal PV Role & Documentation

• Serve as Local Legal PV Responsible Person.
• Maintain and update the Pharmacovigilance System Master File and ensure oversight of local commitments.

WHO YOU ARE

• Confirmed practical experience in pharmacovigilance
• Ability to work with a high degree of autonomy
• Comprehensive understanding of drug safety regulations and obligations
• Proven leadership or influencing skills
• Ability to represent Company externally
• Excellent communication skills
• Very good written and spoken English

TYPE OF CONTRACT

Chemical Contract – starting with 1 year contract