Manager, Patient Safety

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