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Verfügbar
Stundensatz
Auf Anfrage
Vororteinsatz
Nicht möglich

Persönliche Daten

Nationalität
Deutschland
Beruflicher Status
Freelancer
Berufserfahrung
29 Jahre, 6 Monate
Sprachkenntnisse

English (Fließend)

Beschreibung

My professional experience and knowledge are described in detail in the Appendix "prof. knowledge" attached below.

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prof. knowledge

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Statistik von Dr. Pharmacist

Mitglied seit 27.08.2012
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PROFESSIONAL KNOWLEDGE 

 
 
 

 

Research and Development: 

 

− 

Qualified Person according to Art. 48 of EU Directive 2001/83/EC, 
Qualified Person for Pharmacovigilance according to Art. 103 of EU Di-
rective 2001/83/EC, 
Qualified Person for Scientific Service according to Art. 98 of EU Direc-
tive 2001/83/EC, 
Qualified Person designated as responsible for wholesale distribution 
according to Art. 79 of EU Directive 2001/83/EC, 
responsible person for narcotics according to German controlled sub-
stances legislation (BtMG). 

− 

Strategies for Marketing Authorisation (MA) applications, MA-
maintenance: variations, renewals. 

− 

Dossier writing, Part I and II / CTD-Modules 1 

– 5 (Modules 4 and 5 for 

generics); performance of application procedures: national, EU (DCPs 
and MRPs) and Switzerland. 

− 

Scientific and RA relevant evaluation including bioequivalence-studies 
of product licensing and co-operation offers. 

− 

Writing of pharmaceutical expert reports / Quality Overall Summaries 
according to § 24 AMG and Notice to Applicants. 

− 

Medical devices (infusion pump, class IIb). 

− 

Quality Assurance and Stability Testing on drug products and active 
pharmaceutical ingredients, contact for contract manufacturers. Super-
vision and writing of Product Quality Reports (PQR) according to Part I 
of the EU Guidelines to Good Manufacturing Practice Medicinal of 
Products, section 1.5; assignment and supervision of On Going Stabil-
ity projects according to Part I of the EU Guidelines to Good Manufac-
turing Practice Medicinal of Products, sections 6.23 

– 6.33 

− 

RA-Compliance: Writing, inspection and release of test and manufac-
turing procedures before / after MA-approval or variation-approval in 
co-operation with corresponding contract manufacturers including writ-
ing of required variation documentation. Writing, inspection and release 
of Product Data Sheets. 

− 

Batch release of medicinal products, intermediates of medicinal prod-
ucts (e.g. granulates for direct compression) and active pharmaceutical 
ingredients according to §§ 16, 17 AMWHV. 

− 

Batch import of medicinal products, intermediates of medicinal prod-
ucts and active pharmaceutical ingredients manufactured in Non-EU- / 
-EEA Member States according to §§ 72, 72a, 73 AMG. 

− 

Writing of Technical Agreements and Specification of GMP-
Responsibilities for Contract Manufacture according to § 9 AMWHV. 
To date agreements finalised with about 70 contract manufacturers in 
Germany and abroad (EU, China, India, Jordan, Russia, Thailand, 
Turkey, USA). 

− 

Writing of Standard Operation Procedures (SOPs) and Site Master 
Files. 

− 

Supplier qualification and GMP-auditing according to § 11 AMWHV: 
Manufacturers for solid oral dosage forms, injections, QC laboratories, 
primary and secondary packagers, warehousing of medicinal products. 

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− 

Preparation, performance and participation on side of the applicant at 
official GMP-inspections conducted by the authorities of Saxony-
Anhalt, Upper Bavaria and Düsseldorf for application and maintenance 
of a manufacturing authorisation, wholesaler authorisation and/or im-
port authorisation according to §§ 13, 52a and 72 AMG. 

− 

Preparation, performance and participation as Safety Officer on side of 
the applicant at official inspections on medical devices conducted by 
the authorities of Düsseldorf and Münster according to § 26 MPG. 

 
 
 

 

Scientific Product Management: 

− 

Oncology 

− 

Pain therapy (WHO-step III) 

− 

Scientific coaching of sales representatives 

− 

Application / maintenance of trade marks 

− 

Preparation of new market launches 

− 

Research of potential cooperation partners 

 
 

 

Compulsory Health Insurance Fund: 

− 

Negotiation and elaboration of rebate- and cooperation contracts with 
pharmaceutical companies according to § 130a SGB V 

 
 
FURTHER QUALIFICATIONS:  Foreign languages: 

English very well in speaking and writing, 

 

 

  

 

 

French well in speaking and writing, 

 

 

  

 

 

Italian and Spanish, basic knowledge. 

 

 

  

 

 

Passive knowledge in technical terminology of 

 

 

  

 

 

many other European languages like Dutch, 

 

 

  

 

 

Portuguese, Scandinavian languages. 

 
 

 

Sound knowledge in data processing:  Microsoft Office, graphics and  

 

 

  

 

 

 

 

picture revision, internet, research 

 

 

  

 

 

 

 

in data bases, document mana- 

 

 

  

 

 

 

 

gement, etc. 

 

 

  

 

 

 

 

basic knowledge in SAP 

 
 
 
SCIENTIFIC MEMBERSHIPS:  Gesellschaft Deutscher Chemiker, Fachgruppe Medizinische Chemie 

(German Society of Chemists, section of Medicinal Chemistry); 

 

Deutsche Gesellschaft für Regulatory Affairs (German Society of Regula-
tory Affairs); 

 

 

2 industrial working groups Regulatory Affairs, industrial working group 

 

 

 Pharmaceutical Quality 

 
 
 
SCIENTIFIC PUBLICATIONS:  Several scientific publications in international journals