Birgit Schmid Email & Phone Number

Basel, Baselstadt, Ch

Since June 2010, I have held different QA roles in Novartis within Global Drug Development QA providing quality support and guidance in the areas of Drug Safety/ Pharmacovigilance and Medical/ Commercial.For role specifics and relevant achievements see further down below.My general duties in QA have included:- Contribution to investigations of issues/ deviations- Contribution to preparation & management of global system audits and global Health Authority (HA) Inspections- Approval of corrective and preventive action (CAPA) plans for numerous internal & external PV audits - Driving action closure through close collaboration and follow-up with involved business partners - Support auditor- Performing trend analysis for PV audit findings- Provision of training for deviation management and audit follow-up processes/ systems- Deputizing for my manager in my current role as Senior Manager

Basel, Baselstadt, Ch

As QA Manager Medical & Commercial Operations QA renamed to CMO QA in summer 2016 I have provided quality support and oversight for medical and commercial activities in accordance with my general duties listed above and I have actively participated in required Governance Boards.In addition, I have contributed to the establishment of governance for non-interventional studies (NIS), patient support programs (PSPs), and digital and social media and participated in the verification of its local implementation for PSPs during country visits. And I did support two global remediation projects for NIS.Since 2015, I have been providing ad hoc operational support for NIS study teams across all therapeutic areas.

Basel, Baselstadt, Ch

As QA Process and Compliance Expert I have provided QA support to Drug Safety in accordance with my general duties listed above.And I have participated in two global QA projects, one concerning a global CAPA verification through outsourced audits of patient support activities, and the other one concerning the implementation of an end-to end process and system for deviation handling in development including the training of relevant roles globally.

Durham, North Carolina, Us

In my role as Medical Project Manager and in collaboration with several project teams and internal and external stakeholders, I have been overseeing and providing direction for safety projects including clinical trials and post-marketing studies to ensure they run on time and budget, and in accordance with client contract, SOPs, and regulatory guidelines. My major achievements included the successful set up and management of a post-marketing PV system for a European spin off specialty company and the management of safety reporting for a Biotech company running global interventional trials.

Amsterdam, Amsterdam, Nl

As Senior Drug Safety Scientist I have authored aggregate safety reports (PSUR, Summary Bridging Report) and contributed to the Safety Data Review Group, the development of the Core Safety Information in the CDS, and Safety Data Exchange Agreements. Daily operations included processing of safety data collected worldwide from marketed products, generating queries and following up on cases, and expediting them to Regulatory Authorities as required.

Basel, Basel-Stadt, Ch

I have gained limited practical study site experience as Clinical Study Coordinator tasked to execute studies according to sponsor’s requirements, protocol and ICH-GCP. I gained practical insight into key responsibilities including the investigator file, subject eligibility, enrolment, drug accountability, ordering and storage, collection of subject’s medical data and case report form (CRF) completion, reporting of serious adverse events (SAEs) and query resolution.

Basel, Baselstadt, Ch

As Clinical Safety Scientist, I have performed medical and regulatory evaluations of spontaneous and literature adverse event (AE) reports including the review of AE coding, case narratives and other medical information, assessment of AEs against Investigator Brochures, Basic Product Information and EU SmPC for labeling status.In addition I have compiled global PSURs and medically commented line-listings.

Durham, North Carolina, Us

I have started my professional career in a Contract Research Organization (CRO) as Drug Safety Associate reviewing and processing safety data collected worldwide both from clinical trials and marketed products. and contribute to the elaboration of company core data sheets.

Edmonton, Ab, Ca

The objective of my research at the Perinatal Research Centre was to assess the potential role of IL-1 β and IL-6 in the transcriptional regulation of the human Oxytocin receptor gene, in vitro.We hypothesized that IL-1 β and IL-6 induce OT receptor gene expression in human myometrial cells and this is mediated by the transcription factor nuclear factor IL-6 (NF-IL6) and cognate response elements in the 5’ flanking region of the OT receptor gene.MSc Thesis Title: Regulation of the human oxytocin receptor gene by interleukin-1β and Interleukin-6 in vitro.

Basel, Baselstadt, Ch

As trainee I joined Oncology Research in a molecular biology lab with the purpose to broaden my scientific background and to explore molecular biology.I have acquired all basic skills of PCR techniques including cloning, plasmid construction and DNA work, as well as the standard techniques of cellular reporter identification and protein analysis.

Allschwil, Basel-Country, Ch

The objective of my graduate research was to investigate the cytotoxic effects of CGP 40215 on Trypanosoma brucei rhodesiense. CGP 40215 was synthesized as derivative of the potent SAMDC inhibitor methylglyoxal (bis-guanylhydrazone) at Ciba-Geigy AG Basel in 1993 and had already shown good in vitro activity against T. b. rhodesiense and T. b. gambiense. It also inhibited in a cell free system, trypanosomal s-adenosylmethionine decarboxylase (SAMDC) an important enzyme of the polyamine biosynthetic pathway.Diploma (equivalent to an MSc )Thesis Title: Cytotoxic effects of CGP 40215 on the bloodstream forms of Trypanosoma brucei rhodesiense.

As trainee I joined the Fungicide Resistance Lab in Ciba-Geigy Plant Protection to develop in the area of phytopathology a method for sensitivity testing in a controlled environment of Uncinula necator against fingicide and testing of longterm storage of U. necator by cryoconservation.The projects involved microbiological working methods with the obligate biotrophic plant pathogen, planning, conducting and alyzing experiments, and documentation. I have also worked in the green house caring for the plants (hosts).

European Course In Pharmaceutical Medicine

Master Of Science (Msc), Medical Sciences - Obstetrics And Gynecology

Master Of Science (Msc), Biology - Medical Parasitology