Manager, Patient Safety

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