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 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).
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