Syed Saadi Manzoor

Managed local Individual Case Safety Reports (ICSRs) for suspected adverse drug reactions, including query management and follow-up reporting. Coded ADRs and concomitant medications using MedDRA/WHO DD and supported local risk minimization measures for emerging safety concerns.

Processed individual case safety reports (ICSRs), managed safety queries, and coded locally suspected ADRs and serious adverse events. Conducted follow-ups and translations and supported local risk minimization measures for urgent safety restrictions and emerging safety concerns.

Supported GMP/GDP regulatory compliance through investigation liaison, data verification, and monitoring visit report writing. Planned and executed change control requests and supplier notifications, ensuring adherence to required manufacturing and distribution standards.

Performed migration and process risk analyses for GMP production activities including cleaning and method validation support, qualification, and engineering standards. Used Veeva Vault QMS for quality risk management workflows, data editing/correction, migration, and review/approval support.

Authored and maintained regulatory documentation for in vitro diagnostics, including Product Master File (PMF) submissions for CE marking. Prepared and verified EU IVDR 2017/746 documentation, managed labeling records, and supported declarations of conformity and device risk analysis.

Developed technical documentation for IVD performance evaluation, risk analysis, and labeling activities in line with EU Regulation 2017/746. Gained practical microbiology experience and supported regulatory documentation work using Saperion ECM.

Provided IT system support for GMP/GDP compliance activities, including validation document review and system documentation. Supported risk analysis and supplier qualification/requalification documentation as part of rollout and reporting deliverables.

Led process engineering and quality control activities for microbiological testing documentation and industrial hygiene. Managed process performance activities and documentation work, including Veeva Vault QMS usage and data migration support.

Supported EU IVDR 2017/746 implementation work alongside scientific research activities, contributing to reporting and documentation. Prepared supporting materials including MSDS processing, regulatory labeling compliance, and verification documentation using Saperion.

Conducted customer satisfaction and opinion surveys by phone while adhering to established study protocols. Supported clinical research operations including data editing/correction, data review/approval, and clinical trial-related activities aligned to GCP.

Engaged with medical doctors, pharmacists, and hospitals to promote pharmaceutical and medical products across various indications. Supported related documentation activities including IT system support/rollout documentation and GMP-oriented intended purpose definition and migration risk analysis.

Master's degree in Drug Regulatory Affairs (MDRA), including training in medical device regulations. Completed the program from 2021 to 2024.

Completed an MSc program in Master Drug Regulatory Affairs (MDRA) at the University of Bonn from September 2021 to February 2024.

Clinical Trial Management course covering clinical trial management and monitoring from 2012 to 2013.

Completed a Clinical Trial Management course covering central monitoring and plausibility control from April 2012 to March 2013.

Professional training course for Clinical Research Associate completed between 2010 and 2011.

Earned a Bachelor of Science (BSc) in Applied Biology from September 2002 to August 2005.

Bachelor of Science degree in Applied Biology from 2002 to 2005.

Preparatory Studienkolleg course covering German language as well as biology and medicine from 2000 to 2002.

Internship as a Clinical Research Associate at ZKSE (Centre for Clinical Research) in 2011.

Completed an internship as a Clinical Research Associate at ZKSE (Institute for Medical Informatics, Biometry and Epidemiology) from March 2011 to May 2011.

Completed a higher secondary school preparatory course in German language, Biology, and Medicine from August 2000 to June 2002.

Bachelor of Science degree in Biochemistry, Chemistry and Microbiology (Medical Microbiology) from 1997 to 1999.