Jan Kolouch work email
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As a seasoned Pharmacovigilance (PV) professional with a pharmacy background, I have held various senior positions and currently serve as CEO, EU QPPV, and Strategic PV Advisor. My expertise spans key areas such as EU QPPV, signal management, ICSR management, EudraVigilance and XEVMPD set-up and maintenance, PSMF development and maintenance, medical writing (PSURs, RMPs, DSURs), safety database administration, audits and inspections, and CAPA management.Throughout my career, I have significantly contributed to the development and integration of a medium-sized PV service provider into a larger organization. I pride myself on being highly focused, positive, open-minded, and detail-oriented, with a strong eagerness to learn and adapt. My approach is always to find the best solutions tailored to each client's needs.I have collaborated with colleagues and clients across multiple regions and have led teams ranging from a few members to over 250 direct and indirect reports.For any pharmacovigilance/safety related questions, feel free to reach out via info@nextpvservices.com.
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Ceo And Co-FounderNextpv ServicesPrague, Czechia
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Eu Qppv & Strategic Pv AdvisorNextpv Services Dec 2021 - PresentPrague 3, Prague, CzEstablishment and maintenance of a PV system, including review/approval of PSMFHaving an overview of medicinal product safety profiles and any emerging safety concernsEnsuring conduct of PV and submission of all PV-related documents in accordance with the legal requirements and GVPExpert advice on PV activities and respective procedures
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Ceo & Co-FounderNextpv Services Oct 2021 - PresentPrague 3, Prague, CzManaging the overall operations and resources of a company Business developmentQuality management, policy, targetsOversight and support of respective departments within the company
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Dia TrainerDia Jun 2017 - PresentWashington, Dc, Us▪ EudraVigilance training on electronic reporting of ICSRs in the ICH E2B(R3) format▪ eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training▪ Signal Management▪ PSURs/PBRERs -
Head Of Pharmacovigilance And Clinical Safety DepartmentPvpharm Nov 2020 - Sep 2021Almería, Andalusia, EsManagement of day-to-day operations within the PVCS department and interaction with the team and top managementExpert advice in pharmacovigilance and clinical safetyOversight and leadership of PVCS departmentEffective operation of PV and Clinical Safety projects in compliance with respective contracts and legislationEstablishment of company direction for pharmacovigilance and clinical safety activities -
Pharmacovigilance ConsultantPvpharm Aug 2020 - Sep 2021Almería, Andalusia, Es
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Head Of Benefit-Risk Management DepartmentPrimevigilance Ltd. Feb 2020 - Jul 2020Guildford, Surrey, GbLeadership in pharmacovigilance activities, expert advice in areas of pharmacovigilanceProviding support to other departments of the company in all borderline areasOversees and harmonises processes and activities within the scope of department, including but not limited to: Signal management, Additional risk minimisation measures coordination, implementation, emergent safety issues, crisis management, safety communication, safety variations support, reference safety informationMotivation and line management of 12+ colleagues (within the whole department) with several direct reports -
Eu QppvPrimevigilance Ltd. Oct 2019 - Jul 2020Guildford, Surrey, GbEstablishment and maintenance of a PV system, including review/approval of PSMFHaving an overview of medicinal product safety profiles and any emerging safety concernsEnsuring conduct of PV and submission of all PV-related documents in accordance with the legal requirements and GVPReview/Approval of RMP, PSURMaintaining up to date knowledge of current regulations and collaborate with Global PV on regulation changesParticipating in all relevant meetings or committees of MAH and/or contractual arrangementsFulfilling all other legal requirements in this role and having oversight over functioning of the system and also over delegated activities.
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Deputy Eu QppvPrimevigilance Ltd. Nov 2016 - Jul 2020Guildford, Surrey, Gb▪ PSMF preparation, maintenance▪ Contribution to the establishment and maintenance of PV System▪ Oversight over functioning of the PV system in relevant aspects▪ Communication with national competent authorities▪ Review of SDAs▪ Review/approval of RMPs/PSURs▪ NOTE: On 1st March 2018, European Pharminvent Services officially changed its name to PrimeVigilance
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Head Of Icsr Management Unit/Pharmacovigilance DirectorPrimevigilance Ltd. Jul 2019 - Jan 2020Guildford, Surrey, GbLeadership in pharmacovigilance activities, expert advice in areas of pharmacovigilance Providing support to other departments of the company in all borderline areas Oversees and harmonises processes and activities within the scope of the Unit, including but not limited to: ICSR receipt, processing from all types of reports originating from all sources, reconciliation, interaction with other departments, adjusting procedures as per client’s needs, discussing regulatory reporting requirements, where necessary, personal data protection, PQC, PASS, MRPs, PSPs, workflow management, SAE/SUSAR management Motivation and line management of 200+ colleagues (within the whole unit) with several direct reports
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Project ManagerPrimevigilance Ltd. Aug 2014 - Oct 2019Guildford, Surrey, Gb▪ Representing client's interest with the aim of achieving client's goals and objectives▪ Client's support within various activities, including direct communication with NCAs, safety database queries, etc.▪ SOPs / WINs preparation according to client's needs▪ Testing procedure with various NCAs for E2B transmission of ICSRs▪ Team-leading▪ NOTE: On 1st March 2018, European Pharminvent Services officially changed its name to PrimeVigilance
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Pharmacovigilance Director / Head Of Data Management UnitPrimevigilance Ltd. Jun 2018 - Jun 2019Guildford, Surrey, Gb▪ Leadership in pharmacovigilance activities, expert advice in areas of pharmacovigilance▪ Providing support to other departments of the company in all borderline areas▪ Maintenance and improvement of processes covered by Data Management Unit across various clients (innovative/generic/biotech): ICSR management (both solicited and unsolicited reports), personal data protection, PQC and Medical information interaction, computerised systems in PV (including validation), web page/social media monitoring, global and local literature monitoring, XEVMPD▪ Motivation and line management of 18+ colleagues (within the whole unit) with several direct reports
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Associate Director, Pharmacovigilance / Head Of Data Management UnitPrimevigilance Ltd. Dec 2017 - May 2018Guildford, Surrey, Gb▪ Maintenance and improvement of processes covered by Data Management Unit across various clients (innovative/generic/biotech): ICSR management (both solicited and unsolicited reports), personal data protection, PQC and Medical information interaction, computerised systems in PV (including validation), web page/social media monitoring, global and local literature monitoring, XEVMPD▪ Motivation and line management of 15+ colleagues (within the whole unit) with several direct reports▪ NOTE: On 1st March 2018, European Pharminvent Services officially changed its name to PrimeVigilance
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Associate Director, Pharmacovigilance / Head Of Clinical Trials UnitPharminvent Oct 2015 - Nov 2017Vysehrad, Prague 4, Cz▪ Management of Clinical Trials Unit with focus on SAE/SUSAR management, reconciliation, unblinding, protocol review, subject data protection▪ PASS / PAES management▪ Harmonization of procedures throughout various clients▪ Update and creation of relevant documents - SOPs, WINs, Safety Management Plan▪ Team-leading -
Senior Pharmacovigilance SpecialistPharminvent Aug 2014 - Sep 2015Vysehrad, Prague 4, Cz▪ PV documents preparation – RMP, PSUR▪ ICSR management (pre- & post-marketing) - SOPs / WINs preparation, expedited reporting to NCAs, reconcillation with license partners▪ SDEA management▪ MedDRA coding – advanced user▪ XEVMPD – data entry / update ▪ Safety database administrator
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Pharmacovigilance SpecialistPharminvent Sep 2013 - Jul 2014Vysehrad, Prague 4, Cz• PV documents preparation - RMP, PSUR• ICSR management (pre- & post-marketing)• Continuous benefit-risk evaluation (signal management, risk management)• Global literature monitoring
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Pharmacy InternShoppers Drug Mart Jul 2013 - Aug 2013Toronto, Ontario, Ca -
Pharmacy InternBenu Česká Republika A.S. Nov 2012 - Feb 2013Praha 15, Hlavní Město Praha, Cz -
Pharmacy InternCommunity Pharmacy Aug 2012 - Nov 2012
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Advertising And Public Relations Department ManagerIntention Dec 2007 - Jul 2011Devising presentations for advertised products
Jan Kolouch Skills
Jan Kolouch Education Details
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Charles UniversityPharmacology And Toxicology -
Charles UniversityPharmacy
Frequently Asked Questions about Jan Kolouch
What company does Jan Kolouch work for?
Jan Kolouch works for Nextpv Services
What is Jan Kolouch's role at the current company?
Jan Kolouch's current role is CEO and Co-Founder.
What is Jan Kolouch's email address?
Jan Kolouch's email address is ko****@****ent.com
What schools did Jan Kolouch attend?
Jan Kolouch attended Charles University, Charles University.
What skills is Jan Kolouch known for?
Jan Kolouch has skills like Pharmacovigilance, Gvp, Clinical Trials, Icsr Management, Basecon, Xevmpd, Pharmacology, Pharmaceutical Industry, Eudravigilance, Safety Databases.
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