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 RESPONSABILITIES:
Patient Centricity & Strategic Partnership
- Integrate local insights into decision-making and agevolazioni/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).