Manager, Patient Safety

Altro; Pescara; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global pharmaceutical company is seeking a Manager, Patient Safety in Pescara, Italy. This role involves integrating local insights for decision-making, providing strategic input on studies, and acting as a subject matter expert in product safety. The ideal candidate will have proven experience in pharmacovigilance, excellent communication skills, and the ability to work autonomously. A one-year contract starts with this position, offering a dynamic work environment.

Competenze

• Confirmed practical experience in pharmacovigilance.
• Ability to work with a high degree of autonomy.
• Comprehensive understanding of drug safety regulations.
• Proven leadership or influencing skills.
• Ability to represent the company externally.
• Excellent communication skills in English.

Mansioni

• Integrate local insights into decision-making.
• Provide strategic input on studies and programs.
• Act as the local subject matter expert for product safety.
• Manage internal audits and regulatory inspections.
• Develop and update local Risk Management Plans.
• Lead local communication of safety information.
• Ensure timely submission of safety reports.
• Build strong business relationships.

Conoscenze

Practical experience in pharmacovigilance

Ability to work autonomously

Understanding of drug safety regulations

Leadership skills

Excellent communication skills

Written and spoken English proficiency

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