Wildlife photography
DUŠAN VAINER
PV Specialist/CTA
Světlá nad Sázavou,Vysocina
Summary
Experienced Pharmacovigilance and Drug Safety Specialist with a solid 20-year career in the pharmaceutical industry. Proven expertise in ensuring the safety and efficacy of medications, adhering to regulatory guidelines and industry standards. Conducts thorough risk assessments, processing of adverse events, literature and research, clinical trials always strong attention to detail and a commitment to maintaining the highest level of patient safety.
Overview
28
28
years of professional experience
2
2
years of post-secondary education
1
1
Language
Work History
INDEPENDENT QUALITY REVIEWER, TRAINER, TEAM LEAD
ACCENTURE SERVICES
Prague, Hlavni Mesto Praha
02.2021 - 04.2024
- Perform quality review of ICSRs
- Line listings and reports preparation and submission as per client SOPs
- Participation on audits (internal and external) and inspections
- Adequate training of the associates on the SOPs and Client's policies
- Create training plans for new joiners and cross trained FTEs as per the Client approved training plan
- Evaluate the team's performance in terms of productivity and quality
- Trained and mentored 20 new personnel hired to fulfill various roles.
- Enhanced team collaboration by regularly providing constructive feedback to fellow reviewers.
- Increased review accuracy by implementing a comprehensive training program for new reviewers.
- Maintained strong attention to detail while reviewing numerous documents daily, ensuring consistent quality and accuracy.
- Supported continuous improvement initiatives by actively participating in team meetings, trainings, and workshops focused on enhancing reviewer skills and processes.
PHARMACOVIGILANCE SPECIALIST
SOTIO / ACCORD RESEARCH
06.2016 - 04.2020
- ICSRs processing, case narratives writing, safety database maintenance
- Ensuring relevant case reconciliation
- Preparation of line listings for safety reports i.e
- Periodic safety reports, ad hoc safety reports etc
- Assessed and distributed pharmaceutical product adverse event documents.
- Improved regulatory compliance with thorough documentation of adverse events and follow-up actions.
- Reviewed, compiled and analyzed data for safety database management.
- Supported inspections, visits and audits as well as CAPAs management.
- Authored and managed regular safety update reports.
- Participated in internal audits as well as external inspections conducted by regulatory authorities, demonstrating a solid understanding of applicable regulations and guidelines.
SENIOR DRUG SAFETY SPECIALIST
PAREXEL INTERNATIONAL
09.2012 - 06.2016
- ICSRs processing, case narratives writing, safety database maintenance
- ICSR reconciliation
- Supported audit procedures to check all procedures, processes and work standards.
- Conducted safety training and education to employees to increase awareness of safety hazards and empower employees to work safely.
- Served as the primary liaison between the company and regulatory agencies during inspections or audits, addressing any concerns raised and ensuring timely resolution of cited issues.
ASSOCIATE START UP SPECIALIST
QUINTILES CZECH REPUBLIC
08.2011 - 08.2012
- Preparation of Ethic Committees submissions (Informed consent, Protocol Synopsis, site-specific documents, communication with sites and Clients)
- Design and preparation of Clinical Trial Agreements including budget for Hospitals and Investigators
- CTMS maintenance and updating of database of clinical trials
- Clinical team support
PHARMACOVIGILANCE SPECIALIST
ROCHE PRAGUE
06.2004 - 07.2011
- Pharmacovigilance management - administration of ICSRs
- Clinical trials related pharmacovigilance - in clinical trials where Roche Czech Republic keeps PV responsibilities
- Communication and coordinating with CRA, Investigators, Ethic Committees and Health Authority
- Implementation and testing of E2B systems
- Assessed and distributed pharmaceutical product adverse event documents.
LAB ASSISTANT
INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE
09.2002 - 05.2004
- Isolation of DNA and plasmids, PCR analyses of polymorphism, sequence analyses
- Results database system maintenance
- Ensured accurate test results with proper use of lab equipment and adherence to protocols.
LAB ASSISTANT
CHARLES UNIVERSITY IN PRAGUE - 2ND FACULTY OF MEDICINE IN MOTOL, DPT. OF VIROLOGY
Prague, Hlavni mesto Praha
10.1998 - 08.2002
- Diagnostic Virology diagnostics: Serological methods, screening antibody assay, Immunofluorescence methods, Molecular-biologic methods (PCR)
- Ensured accurate test results with proper use of lab equipment and adherence to protocols.
- Learned multiple molecular biological techniques.
- Worked closely with lab staff on special projects.
LAB ASSISTANT
ECOCHEM
Prague, Hlavni Mesto Praha
09.1996 - 09.1998
- Analyses of metals, pesticides, dioxins, PCBs (ICP, ICP, AAS, UV/VIS, liquid, and gas chromatography)
- Demonstrated flexibility working in a fast-paced and ever-changing environment.
- Prioritized tasks efficiently to meet project deadlines while maintaining high-quality results in a fast-paced laboratory environment.
Education
High School Diploma -
MASARYK SECONDARY CHEMICAL SCHOOL
PRAGUE 09.1994 - 05.1996
Skills
MS Office
Photoshop
DAW
ARGUS
SharePoint
ICH-GCP
Veeva Vault eTMF
Passions
- MUSIC - www.madamvtriku.cz
- WILDLIFE PHOTOGRAPHY
- WRITING - www.dusanovo.cz
Relevanttrainings
- 2003, Laboratory Methods in Medicine
- 2004, Principles of Drug Safety, Management of Safety Reporting
- 2011, Essentials of Clinical Trials
- 2016, ISCH-GCP (regular basis)
- 2017, Advanced MedDRA Coding
- 2020, Veeva Vault eTMF system
- 2020, Web Development
- 2020, Online Marketing
Personal Information
Driving License: B
Interests
Music
Timeline
INDEPENDENT QUALITY REVIEWER, TRAINER, TEAM LEAD
ACCENTURE SERVICES
02.2021 - 04.2024
PHARMACOVIGILANCE SPECIALIST
SOTIO / ACCORD RESEARCH
06.2016 - 04.2020
SENIOR DRUG SAFETY SPECIALIST
PAREXEL INTERNATIONAL
09.2012 - 06.2016
ASSOCIATE START UP SPECIALIST
QUINTILES CZECH REPUBLIC
08.2011 - 08.2012
PHARMACOVIGILANCE SPECIALIST
ROCHE PRAGUE
06.2004 - 07.2011
LAB ASSISTANT
INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE
09.2002 - 05.2004
LAB ASSISTANT
CHARLES UNIVERSITY IN PRAGUE - 2ND FACULTY OF MEDICINE IN MOTOL, DPT. OF VIROLOGY
10.1998 - 08.2002
LAB ASSISTANT
ECOCHEM
09.1996 - 09.1998
High School Diploma -
MASARYK SECONDARY CHEMICAL SCHOOL
09.1994 - 05.1996
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