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
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