Over a decade of hands-on pharmacovigilance experience, covering both clinical trials and post-marketing safety
Managed global and local PV systems, handled medical assessments, case processing, and expedited reporting
PV allrounder: PV expert in various roles, she oversaw compliance metrics, literature surveillance, and reconciliation with global partners
Successfully placed as a Global Safety Manager via K-Recruiting
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Our content and services may vary by location.
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Overview
- Availability
- Up-to fulltime, mainly remote
- Qualification
- PhD in Biochemical Pharmacology
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Pharmacovigilance Manager, PV Compliance, Global PV, Drug Safety, Signal Detection, Case Processing, PV Audit Preparation, SOP Creation, Vendor Management, PV Process Management, ICSRs, Eudravigilance, PSUR, Pharma, Biotech
Key-Facts
Extract from previous activities
Pharmaceutical Company, Germany (via K-Recruiting)
Global Safety Manager
Global Drug Safety Consultant, Case Processing (Clinical Trials and Post-Marketing)
Inspection Readiness & Preparation
Process Evaluation, Amendment and Implementation
CRO, Germany
Pharmacovigilance Specialist
DSUR Contribution, SUSAR Oversight
Clinical Regulatory Intelligence worldwide
Project Oversight
Pharmaceutical Company, Germany
PV Operations Manager
Process Audits PV – Middle East & Africa, Asia, Latin America
Preparation, Document Request, Conduct, Evaluation, Audit report, CAPA Plan and Closure
Pharmaceutical Company, Germany
PV Manager
Distributor Audits PV – USA, China, Slovak Republic, etc.
Preparation, Document Request, Conduct, Evaluation, Audit report, CAPA Plan and Closure
Biopharmaceutical Company, Germany
PV Scientific Consultant
Drug Safety, Pharmacovigilance, Compliance, Reconciliation with world-wide partners, PV Training, Late Case Handling, Deviation and CAPA Management
Set up and monthly evaluation of Key Performance Indicators: Timely Processing of ICSRs, Signal Detection, CCSI Update (SmPC check), PSUR Submission
PV Consulting Company, Germany
PV Scientific Consultant
Local Responsible Person, DACH
Local Literature Search – DACH
Regulatory Intelligence – DACH
Pharmaceutical Company, Germany
PV Manager
PV System Set-up, SOP and WI drafting, Audit preparation, Case Processing
Medical Scientific Inquiries, Query Management, Deviation & CAPA Management, Back-Log Processing
Set-up Local Signal Detection, Interaction with RA, QA etc.
Pharmaceutical Company, Germany
PV Scientific Consultant
Medical Assessment of Adverse Drug Reactions, Submission to Authorities
Global Literature and Competent Authority Screening
SOP and WI drafting and review
Audit & Inspection preparation including document requests
Biopharmaceutical Company, Germany
Local Safety Officer
Local Safety Officer Support DACH – Germany, Austria, Switzerland
Case & Query Management, Reconciliation, PV Metrics, Audit Preparation & Conduct
Pharmaceutical Company, Germany
Drug Safety Consultant
Regional Territory Manager Eastern & Central Intercontinental (ECI - Middle East & Africa, Russia & CIS, Switzerland & SEE, Turkey)
Oversight of PV Compliance on Country Level via weekly Meetings, Key Contact Person between Local Responsible Person and Global Organization, Partner (Service Provider & Distributor) Management
Audit Preparation & Inspection Readiness
Biotech Company, Germany
Local PV Responsible Person DACH
Local PV Responsible Person DACH - Germany, Austria, Switzerland
Oversight PV System – Cases, Local Literature, HA Interactions, Aggregate Reports, Reconciliation, Business Continuity Plan, Management Review, CAPAs & Deviations
Interaction with Global, other Departments, and several Vendors (Vendor Oversight)
Audit & Inspection preparation, participation and follow up actions