Manager, Patient Safety

Iqvia Italia; Pescara; In loco; EUR 50.000 - 65.000; Tempo pieno

Descrizione del lavoro

A global pharmaceutical company is seeking a Manager, Patient Safety in Pescara, Italy. This role involves integrating local insights into decision-making, collaborating with teams, and managing internal processes to ensure compliance with drug safety regulations. The ideal candidate has experience in pharmacovigilance and excellent communication skills. The position offers a chemical contract starting with a one-year term.

Competenze

• 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.

Mansioni

• Integrate local insights into decision-making and benefit / risk management.
• Collaborate with teams to implement safe, compliant solutions.
• Provide strategic input on post-marketing surveillance.
• Monitor safety profiles and emerging concerns.
• Manage internal PV audits and regulatory inspections.
• Develop and update local Risk Management Plans.
• Lead local communication of safety information to authorities.
• Maintain local PV quality systems and procedures.
• Ensure timely processing of Individual Case Safety Reports.
• Serve as Local Legal PV Responsible Person.

Conoscenze

Practical experience in pharmacovigilance

Ability to work autonomously

Understanding of drug safety regulations

Leadership or influencing skills

Excellent communication skills

Very good written and spoken English

Descrizione del lavoro

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.

MAIN TASKS AND 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

IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196 / 2003) - General Data Protection Regulation (13 GDPR 679 / 16 –) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903 / 77).