Job Description:
The Drug Safety Compliance Manager/Deputy EU QPPV works in a team-oriented environment ensuring compliance with global regulatory requirements. They develop compliance reports and metrics, implement corrective/preventative actions to address non-compliance and support the Head Drug Safety Operations and Compliance.
Key Responsibilities:
* Ensure proper configuration of expediting requirements in safety databases.
* Create periodic Compliance/Quality/KPI reports for Global Drug Safety operations and submit to health authorities worldwide.
* Manage deviations and CAPAs for GDS, conduct trend analysis with QA, act as business lead/support internal audits and Health Authorities inspection readiness and management activities.
* Manage business change requests for GDS systems.
* Support pharmacovigilance agreements with license and business partners.
Clinical Trial Activities:
* Review/approve clinical trials Safety Management Plans (SMPs) with Contract Research Organizations (CROs).
* Participate in bid defense meetings and review CRO budget proposals for clinical trials.
Quality System (QS) Documents:
* Monitor and manage GDS quality system documents for timely periodic review.
* Ensure GDS QS documents are up-to-date, reflect current procedures/practices and ensure proper implementation.
Acts as Deputy European Union Qualified Person for Pharmacovigilance (Deputy EU QPPV):
* Contact point for competent authorities during EU QPPV absence.
* Deputize EU QPPV during absence for tasks related to compliance aspects and Idorsia Pharmacovigilance system.
* Act as Trusted Deputy/Responsible Person for Eudravigilance with regards to EVWEB and XEVMPD.
* Support preparation, maintenance and quality control of pharmacovigilance system master file involving cross-functional interactions.
Additional Responsibilities:
* Lead/contribute training activities on 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 or equivalent education in health-related field.
* At least 7-10-year experience in safety, quality assurance and/or Pharmacovigilance audit.
* Experience managing Health Authority PV and GCP inspections.
* Experience writing procedural documents and developing CAPAs.
* In-depth understanding of quality assurance and compliance concepts.
* Good knowledge 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 managing departmental projects or process improvement initiatives.
* Experience in safety data management including 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 ability to work under pressure and meet short timelines.
Business Area:
Global Clinical Development, Drug Safety
Job Type:
Permanent
Job ID
4530