Our Company
We know that drug safety is a matter of confidence - and outsourcing in this field even more so.
The strict secrecy of client data and a loyal behaviour towards our clients are therefore of central importance to us.
Our basic work concept is based on the following pillars:
- living the quality management system as well as our client and entrepreneurial philosophy with all its basic values in our everyday work
- high degree of transparency for our clients
- close agreement with our clients
- the focussed selection of the members of a project team according to the qualifications that meet the client-specific requirements
- flexibility and competence in using time-tested standard procedures or new procedures
- the use of quality assurance procedures for integrity, validity and plausibility tests
- attention to effectiveness under the aspect of a positive cost-benefit ratio
Jobs
Mitarbeiterin/Mitarbeiter für die Abteilung Informationstechnik
Wir suchen zum nächstmöglichen Eintritt eine Mitarbeiterin / einen Mitarbeiter für eine unbefristete Stelle in der Abteilung Informationstechnik.
Die Aufgaben umfassen die folgenden Tätigkeiten:
Softwareentwicklung
Entwicklung und Pflege der firmeneigenen Softwareprodukte vor allem mit Hilfe der Programmiersprachen VB6, VBA und VB.Net
Mitarbeit in Kundenprojekten bei der Entwicklung von Softwareprodukten für die PV
Testung der firmeneigenen Softwareprodukte in Rahmen von Validierungsaktivitäten
Support
Entgegennahme von Supportanfragen zu firmeneigenen Softwareprodukten
Unterstützung der Benutzer bei firmeneigenen Softwareprodukten
Folgende Kompetenzen und Kenntnisse werden vorausgesetzt:
Erfahrung in der Softwareentwicklung mit Visual Basic
Verstehen von Skripten für die Oracle Datenbank
Verständnis für Qualitätssicherung
Einsatzbereitschaft und Flexibilität
eine schnelle Auffassungsgabe, Selbstmanagement und Genauigkeit
Engagement und Teamfähigkeit
gute Deutschkenntnisse in Wort und Schrift
Verstehen von Texten in Englischer Sprache
Wenn Sie Interesse an einer vielseitigen und abwechslungsreichen Tätigkeit haben, freuen wir uns auf Ihr Bewerbungsschreiben mit Angabe Ihres frühestmöglichen Eintrittstermins und Ihrer Gehaltsvorstellung schriftlich (gerne auch per E-Mail) an:
PHARM-SOFT Dr. B. Rodust GmbH
z.Hd. Herrn Paul-Peter Pokojski
Königswall 22
44137 Dortmund
Per E-Mail an: bewerbung@pharmsoft.de
Our Philosophy
Since our company was founded, we, both managers and employees are applying discipline, effort and empathy in order to meet each client’s individual requirements. To keep up a constant readiness for commitment by consciously viewing our clients as partners and internalising partnership behaviour in the everyday work, combined with a high degree of competence of all the persons working in our company, is one of our greatest strength and the basis of ours and hence our clients’ success.
Our understanding of quality comprises the look into our clients’ demands, the requirements made on us and their successful implementation in our daily work by combining our skills and motivation.
This understanding has crystallized in the course of time, as our clients have made individual demands on us. To cope successfully we need to have the ability - which we are glad to show to its fullest - of finding flexible ways and developing new, customized solutions at any time.
Over the years, we have thus gained a large wealth of experience. Always looking for possibilities to further improved time-tested procedures, taking efforts not to prefer the easy to the better or better-suited solution - this is the attitude we keep up to benefit our clients. This attitude also includes effectiveness considerations to achieve a positive cost-benefit ratio for our clients.
Our experience at project level
The following list gives an overview about the main portfolio of our pharmacovigilance Services:
- complete processing of cases from ongoing national and international studies
- complete processing of cases from ongoing observational studies
- complete processing of cases to prepare meta-analyses
- literature processing
- creation of PSUR and DSUR reports
- creation of final study reports
- creation of single case reports
- preparation of SOPs and work instructions
- revision and editing of "old" case data from different sources
- processing of cases from licence partners
- creation of narratives with the purpose of a safety analysis by an independent expert
- online processing of cases in clients’ database
- coding with MedDRA®
- reporting of ICSRs and SUSARs as paper reports and electronically
Our experience as Drug Safety CRO
Our experience as a Drug Safety CRO is based on many projects we managed as part of our cooperation with pharmaceutical companies. We have processed preparations for various indications like e.g. hypertension, allergies, inflammation, neoplasm and with different active substances (see following information).
Our experience on active substances
Ademetionin , Alprostadil , Amiodaron , Amoxicillin , Azathioprin , Azelastin-HCl , Bemetizid + Triamteren , Bleomycin , Buprenorphin , Captopril , Captopril + Hydrochlorothiazid , Carboplatin , Cefotiam , Cetrorelix , Cilostadol , Ciprofloxacin , Cisplatin , Citalopram , Clarithromycin , Clopidogrel , Clotrimazol , Cromoglicinsäure + Dinatriumsalz + Reproterol-HCl , Cyclophosphamid , Cytarabin , Dihydroergotaminmesilat , Doxorubicin , Epirubucin , Ergotamintartrat , Ethinylestradiol + Chlormadinacetat , Ethinylestradiol + Desogestrel , Ethinylestradiol + Norethisteron , Etoposide , Fluorouracil , Fosinopril-Natrium , Fosinopril-Natrium + Hydrochlorothiazid , Flupirtinmaleat , Gatifloxacin , Glyceroltrinitrat , Heparin , Ifosfamid , Impavido , Isosorbiddinitrat , Isosorbidmononitrat , Isradipin , Lipophiler Extrakt aus Sägepalmfrüchten , Lidocaine , Loratadin , Mesna , Methotrexat , Mibefradil , Miltefosine , Mitoxantron , Mizolastin , Moexipril-HCl , Natriumbicarbonat , Naproxen , Naratriptan , Norfloxacin , Omeprazol , Oxaliplatin , Oxybutynin , Ozarelix , Paclitaxel , Pantoprazol , Paracetamol , Penicillamin , Perifosine , Plasmaproteine + Immunglobuline , Polyhydroxyethylstärke , Pravastatin-Natrium , Propanol + Hydralazin + Bendroflumethiazid , Reproterol-HCl , Rotigotin , Salmeterol + Fluticason , Selegilin , Simvastatin , Sitosterin , Tamoxifen , Tamulosin , Tapentadol , Thiamazol , Tramadol , Tramadol + Paracetamol , Trockenextrakt aus Brennesselwurzel , Trockenextrakt aus Goldrutenkraut , Trockenextrakt aus Kürbissamen , Trockenextrakt aus Orthosiphonblättern , Valsartan , Valsartan + Hydrochlorothiazid , Zuclopenthixol
Our experience in the field of information technology
The following list gives an overview about the main portfolio of our pharmacovigilance Services:
- development of databases and tools for pharmacovigilance
- validation of software products and systems
- creation of documents according to GAMP5®
- development of printouts of standardised reporting forms and line listings
- development of interfaces, e.g., for use of terminologies like MedDRA® and WHO Drug Dictionary
- programming with C, C++, C#, .NET, VB, Java, UNIFACE
- database design and administration for Access, Oracle, MySQL and MS-SQL Server
- creation of SQL scripts
- user trainings
- application hosting /application service providing / Software as a Service (SaaS)
- installation and support of hardware systems
- support
- after-sales service and maintenance
Our Employees
Our qualified employees come from the fields of biology, medicine (with various specialities), documentation sciences and information technology. Bundling and combining these qualifications allows us to perform most different tasks for our clients and create solutions for their bottlenecks.
Our dedicated ongoing education programme by external and internal trainings as well as the participation in continuing seminars ensure that the specialization of our employees always meets the requirements of our clients.
According to our client philosophy we make high demands on our existing and new employees. This refers not only to their qualification and ability to fit into our company but in particular to their ability to focus their everyday work on our clients and their needs.
Quality Management System
Drug safety is a field with particularly high importance of legal and ethical standards. Therefore a high quality is a central characteristic of our daily work to be able to meet the applicable standards. Due to this fact we established a quality management system already more than twenty years ago.
Our principles and goals
The success of our company is not only based on the high quality of our services and the professionalism, commitment, motivation and expertise of our employees, but the consistently careful consideration of our clients’ requirements.
In order to know what our clients expect from us, we look into their demands, which are currently characterized by
- increasing concentration on company level
- increasing globalization
- increasing harmonization in the international area
- increasing regulatory requirements
- a highly sensitive public
- increasing shortage of resources
- special requirements on product safety
- special, highly regulated market forms
- high profitability
- high risks
When performing our services, we want to
- raise our clients’ satisfaction by first-class service
- relieve the client in his daily work, at the same time paying attention to always meeting the strict regulatory requirements and quality standards
- raise the confidence in our work by allowing clients to follow the processing of their projects
- apply great flexibility in implementing our clients’ wishes and thus contribute to their success
- offer our services always at fair prices
- integrate our clients as partners in the development of products and recognize their wishes and demands early
In order to guarantee professional and highly qualitative work by our employees, we are striving to
- promote and strengthen their personal responsibility and own initiative
- promote their entrepreneurial spirit
- create a climate fostering innovation and high performance
- promote open discussions in order to always take the road to future success
- motivate our employees
- recognize the need for continued education early
- respect everyone irrespective of their sex, religion and origin