Drug Safety/Pharmacovigilance Manager

4/2017 – 12/2019

Process of incoming case reports
◼ Creation of narratives
◼ Initital data entry
◼ MedDRA coding
◼ Follow-up handling
◼ Literature case data entry and quality check
◼ E2B reporting
◼ Study case data entry and quality check
◼ Review of Clinical Phase Data and Study Material

Good clinical practice (GCP)

8/2016 – 6/2017

Triage of incoming case reports
◼ Import of literature and Authority cases
◼ Tracking of Invalid cases

Good clinical practice (GCP)

4/2016 – 7/2016

(Email) correspondence in German and English
◼ Accounting and Processing of the Investigator Payments
◼ Accounting and Processing of the Patient reimbursement
◼ Processing the incoming invoices
◼ TMF Tracking

Good clinical practice (GCP)

10/2015 – 4/2016

(Email) correspondence in German and English
Travel bookings
Travel expense accounting
Preparation of the Agenda/meeting minutes
Preparation of Projectmanagment documents/Project plan
General independent office work
Preparation of presentation
Organisation of meetings

Microsoft Office Project Server

2/2014 – 9/2015

Triage of incoming case reports
Case processing (Data Entry, Quality check)
Creation of narratives
Initital/Follow up data entry and Quality check
Quality check of the cases
MedDRA coding
Follow-up handling
Reporting
Reconciliation

ARIS

7/2013 – 12/2013

- Case Processing
- Creation of narratives
- Quality check of the incoming documents
- process of the AE`s and SAE
- Line Listings for PSUR`s

ARIS

1/2013 – 6/2013

Project/Milestone tracking
Activity/Issue and risk management
Work Product Tracking
Daten Management Support
Meeting Management
Mailbox and Project drive Handling
Staff roll-on/roll-off
Work order Management
Timesheets
Laufzettel

1/2006 – 12/2012

Unterstützung des Bereichsleiters im Sekretariatsbereich :

-allgemeine Korrespondenz
- Power Point Präsentationen erstellen
- Unterstützung der Projektleiter
- Datenbank Einträge

1/2003 – 9/2005

Unterstützung des CEO im
Sekretariatsbereich :

-allgemeine Korrespondenz
- Power Point Präsentationen erstellen
- Unterstützung der Projektleiter
- Datenbank Einträge

Eventmanagement:
Planung/Organisation
und Durchführung von internen und externen Meetings

1/1997 – 4/2004

allgemeine Kundenbetreuung