Drug Development Consulting

Pharma IT has an experienced team of Drug Development Consultants ready to assist you with services in all the phases from early phase clinical development until late phase; and well into the post-marketing phase.

Our intern consultants currently cover the following specialty areas:

Where as the following areas are covered by partners and via our extensive freelance consultant database:

If you need support don’t hesitate to contact us.

Meet the Drug Development Consulting team:

Senior Pharma Consultant
Torben Elhauge

Holds more than 25 years’ experience from the Pharmaceutical industry within the CMC area

With an offspring in Analytical development, Torben has a broad experience within all parts of the CMC area from development over validation and registration to GMP release of products.

Torben is experienced in working with Impurities, Stability, Specifications, Release of Investigation Medicinal, CRO’s and Tech Tranfer. Torben have assessed registration files at the Danish Medicines Agency and have written the analytical part of the registration file for several products.

Torben holds a master’s degree in chemical engineering.

GMP
Data Management Consultant
Faiyaz Hussein

Is a Data Manager with 15 years of Clinical Research experience with respect to Project Management, Data management, eCRF and database designing, validation of IT systems, integration testing, reporting on varied EDC systems, electronic patient reported outcomes ePRO, edevices in diabetes care (Insulin pumps, CGM) and submission to Health Authorities with major pharmaceuticals.

21 CFR Part 11, GCP, Six Sigma Green, BASE SAS, Inform, Medidata Rave, Clintrial 4.4 EDC’s and OC/RDC
Data Management Consultant
Evangelos Kapris

Experienced Clinical Data Manager with experience within: CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk-based monitoring and data management oversight.

 

 

M.Sc. Data Mining
Senior Medical Writer
Kaushik Sengupta

Senior Medical Writing Consultant with over 8 years of experience from the pharmaceutical industry as a Senior/Expert Medical Writer. Has prepared numerous high-quality regulatory and research documents for leading global pharmaceutical companies. Typically, these documents have been based on Phase I–IV studies from most major therapeutic areas. Holds a Master in Dentistry from Canada and has pursued a PhD in epidemiology from Copenhagen University.

Data Management Consultant
Jens Sørensen

Clinical Data Manager with pharmacy background and 18 years of experience from the pharmaceutical industry. Experience as both insourced and outsourced consultant with all aspects of clinical data management including; CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SAS and SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk based monitoring and data management oversight.

Pharmacovigilance Consultant
Maria Skou Andersen

Cand.pharm with five years of case processing experience in department of Global Pharmacovigilance. Experienced with handling adverse event reports including book-in, data entry, verification, reconciliation and MedDRA coding of spontaneous and study cases into the safety databases Argus and Empirica. 

EDMS system expert with Veeva implementation experience.

Certified Veeva Vault Administrator
Senior Pharmacovigilance Consultant
Kristine Kornøe

Experienced in clinical and postmarketing safety after working 6 years as a Drug Safety Advisor in a large danish HQ. Experience include: Signal Detection, PSUR/PBRER and DSUR writing and submission; Risk Management Plans; maintaining and building quality management systems; pharmacovigilance training, E2B reporting, ICSR case processing and reporting.

Senior Pharmacovigilance Consultant
Louise Søgaard Nielsen

10 years of experience as a pharmacovigilance professional. Experience with all aspects of pharmacovigilance including; ICSR case processing and reporting, Signal Detection, PSUR and DSUR writing and submission; Risk Management Plans and maintaining and building quality management systemst a larger pharmaceutical company in the Copenhagen area.

Senior Pharmacovigilance Consultant
Mie Altermann Sørensen

Pharmacovigilance professional with 6 years of experience from the pharmaceutical industry. Experience from working in both headquarter and affiliate. Includes: Signal detection, literature monitoring, pharmacovigilance training, individual case safety report processing, including coding and narrative writing, scientific evaluation and reporting. Medical information activities; writing medical responses to health care professionals, direct costumer contact. Studying Master of Medicines Regulatory Affairs. 

Director of Pharmacovigilance
Ea Marie Holst
+ 45 30 22 23 21

More than 13 years of experienced as a pharmacovigilance professional. Experience from both headquarters and affiliates with all aspects of pharmacovigilance including; Signal Detection, PSUR/PBRER and DSUR writing and submission; Risk Management Plans; maintaining and building quality management systems; pharmacovigilance training in the companies and outside, E2B reporting and testing, ICSR case processing and reporting. Experience with Medical Information and Promotional Material Review.