Drug Safety Compliance Manager / Deputy EU QPPV
Job Summary:
The Drug Safety Compliance Manager will ensure compliance with global regulatory requirements, develop compliance reports/metrics and implement corrective/preventative actions to address any identified non-compliance.
Key Responsibilities:
Pharmacovigilance Compliance activities:
* Ensure proper configuration of the expediting requirements in the safety database.
* Create periodic Compliance/Quality/KPI report to monitor Global Drug Safety (GDS) Operation activities, reporting and submission to health authorities worldwide.
* Manage deviations and CAPA for GDS and conduct trend analysis in collaboration with QA.
* Act as business lead and/or support GDS internal audits and Health Authorities inspection readiness and management activities.
* Manage business change requests for GDS systems.
* Support management of pharmacovigilance agreements with license and business partners.
Clinical Trial Activities:
* Review/approve clinical trials Safety Management Plans (SMPs) with Contract Research Organizations (CROs) in collaboration with Drug Safety Operations.
* Participate in bid defense meetings and review CRO budget proposals for clinical trials.
Quality System (QS) Documents:
* Monitor and manage GDS quality system documents and ensure timely periodic review.
* Ensure that GDS QS documents are up to date, reflect the current procedure or practice and ensure proper implementation.
Acts as Deputy European Union Qualified Person for Pharmacovigilance (Deputy EU QPPV):
* Contact point for the competent authorities in Member States and the European Medicines Agency during absence of the EU QPPV.
* Deputize EU QPPV during absence for tasks and responsibilities related to compliance aspects and Idorsia Pharmacovigilance system.
* Act as Trusted Deputy/Responsible Person for Eudravigilance with regards to EVWEB and XEVMPD.
* Support the preparation, maintenance and quality control of the pharmacovigilance system master file (PSMF) involving cross-functional interactions.
Additional responsibilities:
* Lead/contribute training activities for new/existing GDS employees or other functions/external service providers on all quality and compliance aspects associated with pharmacovigilance.
* Support system upgrade projects including testing and validation activities.
* Support data migration and cleaning activities.
Candidate Requirements:
* University degree in life science (Pharmacy, nurse, MSc, PhD) or equivalent education in health-related field.
* At least 7-10 years experience in safety, quality assurance and/or Pharmacovigilance (PV) audit.
* Experience in managing Health Authority PV and GCP inspections.
* Experience in writing procedural documents and developing corrective and preventive action plans (CAPAs).
* In depth understanding of quality assurance and compliance concepts.
* Good knowledge and understanding of ICH guidelines, European regulations, US Code of Federal Regulations, and other relevant pharmacovigilance regulations worldwide.
* Broad knowledge of all aspects of pharmacovigilance activities and risk management.
* Experience in managing departmental projects or process improvement initiatives.
* Experience in safety data management including the collection, processing and reporting of adverse events.
* In depth knowledge of coding thesauri and medical/drug dictionaries.
* Excellent written and verbal communication skills.
* Excellent organizational, problem-solving and interpersonal skills, and the ability to work under pressure and meet short timelines.
Business Area: Global Clinical Development, Drug Safety
Job Type: Permanent
Job ID: 4530