Ocena ogólna pracodawcy
LAMBDA THERAPEUTIC RESEARCH sp. z o.o.
WARSZAWA, UL. TAŚMOWA 7
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Użytkownik: Administrator
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Rekrutacje prowadzone przez firmę:
Wszystkie (8)
Aktualne ( 0 )
Archiwalne ( 8 )
EU QPPV
Warszawa
Wygasła: 19.04.2024
full-time
umowa o pracę
full office work
specialist (Mid / Regular)
Obowiązki:
- Establishment, maintenance and management of Pharmacovigilance system
- Oversees functioning of pharmacovigilance system in all relevant aspects including its quality system
- Having awareness of any conditions or obligations adopted as part of the marketing authorisation and other commitments relating to safety or the safe use of the product including risk minimisation measures (if any)
- Act as a single contact point for MAH and the competent authorities with 24/7 availability
- Oversees preparation and maintenance of pharmacovigilance system master file (PSMF) in order to promote, maintain and improve compliance with the EU legal requirements
- Oversees the development, validation, operation and change management of the safety database and maintains oversight of the related processes and procedures to ensure that all adverse events reported to the MAH are recorded and accessible through a single point in the EU
- Oversees on-going evaluation of the MAH's authorised products, by signal detection and evaluation
- Ensures a full and prompt response to any request received from the competent authorities in members states and from the agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product
- Ensures that all pharmacovigilance activities within the EU are covered by appropriate SOPs/WIs/Gs, which fully explain the processes and ensures that these SOPs/WIs/Gs are in accordance with relevant regulations
- Oversight and overall responsible to complete the activity for submission of the products details in Article 57 database after approval of MA application
- Being aware of and having sufficient authority over the content of RMPs, aggregate reports, PASS
- Manages/provides support for inspections conducted by regulatory authorities
Ogłoszenie Archiwalne
Ogłoszenie Archiwalne
Deputy EU QPPV
Warszawa
Wygasła: 17.12.2023
full-time
umowa o pracę
full office work
specialist (Mid / Regular)
Obowiązki:
- Establishment, maintenance and management of Pharmacovigilance system
- Oversees functioning of pharmacovigilance system in all relevant aspects including its quality system
- Having awareness of any conditions or obligations adopted as part of the marketing authorisation and other commitments relating to safety or the safe use of the product including risk minimisation measures (if any)
- Act as a single contact point for MAH and the competent authorities with 24/7 availability
- Oversees preparation and maintenance of pharmacovigilance system master file (PSMF) in order to promote, maintain and improve compliance with the EU legal requirements
- Oversees the development, validation, operation and change management of the safety database and maintains oversight of the related processes and procedures to ensure that all adverse events reported to the MAH are recorded and accessible through a single point in the EU
- Oversees on-going evaluation of the MAH's authorised products, by signal detection and evaluation
- Ensures a full and prompt response to any request received from the competent authorities in members states and from the agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product
- Ensures that all pharmacovigilance activities within the EU are covered by appropriate SOPs/WIs/Gs, which fully explain the processes and ensures that these SOPs/WIs/Gs are in accordance with relevant regulations
- Oversight and overall responsible to complete the activity for submission of the products details in Article 57 database after approval of MA application
- Being aware of and having sufficient authority over the content of RMPs, aggregate reports, PASS
- Manages/provides support for inspections conducted by regulatory authorities
- Ensure communication with all relevant people is of a high professional standard, and that records of both internal and external communication are maintained
- Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Company's global Pharmacovigilance requirements
- Deliver training to new joinee and team as per requirement
- Work with the Aggregate report/ ICSR team/Medical review team leader to escalate issues or tasks outside the normal scope of work
- Support group leader for timely submission of ICSR in order to achieve 100% regulatory compliance
- Send and receive ICSR related queries to the regulatory authorities
Ogłoszenie Archiwalne
Ogłoszenie Archiwalne
Medical Information Specialist
Warszawa
Wygasła: 28.12.2022
full-time
umowa o pracę
full office work
specialist (Mid / Regular)
Obowiązki:
- Medical Inquiry Handling
- • Ensure that Medical Inquiry mail box, fax machine, phone and postage are checked daily for ICSRs
- • Tracking and Handling of medical inquiry in accordance with company's controlled documents (e.g. SOPs, Wls, Guide)
- • Logging and updation of inquiry in PrITR database
- • Preparation and communication of inquiry response in liaise with designated medical reviewer
- • Assist designated medical reviewer for follow up of all medical inquiry
- • Reconciliation of medical inquiries received from clients and their affiliates, business partners
- • Reconcile and acknowledge adverse events/product complaints emails in accordance with safety data exchange as per SDEA and PMP
- • SDEA preparation
- Submission
- • Submission of ICSRs to Regulatory authority via Electronic and/or paper format in accordance with companies controlled documents (e.g. SOPs, WIs, Guide) and applicable regulatory guidelines
- • Submission/Locking of cases
- • Receipt of regulatory cases from Eudravigilance
- • Registration of client’s product on XEVMPD
- Secondary responsibilities
- • Case Processing
- • Perform duplicate search
- • Case receipt and tracking
- • Case processing including data entry, Drug coding, MedDRA coding, Listedness, assessment for expediting, narrative writing of ICSR in accordance with Company's controlled documents (e.g. SOPs, Wls, Guide) relevant regulations and guidelines
- • Preparation, revision, review of SOPs, Wls, Templates, guide and guidance training documents
- • Communication of urgent safety issues to Line manager
- • Ensure communication with all relevant people is of a high professional standard, and that records of both internal and external communication are maintained
- • Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Company's global Pharmacovigilance requirements
- • Deliver training to new joinee and team as per requirement
- • Work with the Aggregate report/ ICSR team/Medical review team leader to escalate issues or tasks outside the normal scope of work
- • Support group leader for timely submission of ICSR in order to achieve 100% regulatory compliance
- • Send and receive ICSR related queries to the regulatory authorities
Ogłoszenie Archiwalne
Ogłoszenie Archiwalne
EU QPPV/Local Responsible Person
Warszawa
Wygasła: 15.06.2022
full-time
umowa o pracę
specialist (Mid / Regular)
Obowiązki:
- Establishment, maintenance and management of Pharmacovigilance system
- Oversees functioning of pharmacovigilance system in all relevant aspects including its quality system
- Having awareness of any conditions or obligations adopted as part of the marketing authorisation and other commitments relating to safety or the safe use of the product including risk minimisation measures (if any)
- Act as a single contact point for MAH and the competent authorities with 24/7 availability
- Oversees preparation and maintenance of pharmacovigilance system master file (PSMF) in order to promote, maintain and improve compliance with the EU legal requirements
- Oversees the development, validation, operation and change management of the safety database and maintains oversight of the related processes and procedures to ensure that all adverse events reported to the MAH are recorded and accessible through a single point in the EU
- Oversees on-going evaluation of the MAH's authorised products, by signal detection and evaluation
- Ensures a full and prompt response to any request received from the competent authorities in members states and from the agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product
- Ensures that all pharmacovigilance activities within the EU are covered by appropriate SOPs/WIs/Gs, which fully explain the processes and ensures that these SOPs/WIs/Gs are in accordance with relevant regulations
- Oversight and overall responsible to complete the activity for submission of the products details in Article 57 database after approval of MA application
- Being aware of and having sufficient authority over the content of RMPs, aggregate reports, PASS
- Manages/provides support for inspections conducted by regulatory authorities
- Acts as Local Responsible Person in Poland
- Acts in compliance with local regulation and in accordance with global and local PV procedures
- Oversees functioning of local Pharmacovigilance system in all relevant aspects including local SOPs, Quality Management systems, trainings, records & archival etc
- Support audits and Inspections conducted for local pharmacovigilance activities
- Provision of local regulation for Pharmacovigilance intelligence
- Prompt and effective communication with local regulatory authorities for any safety related issues associated with medicinal products, as and when required
- Collection of locally suspected AE or potential AE reports received at national level (including product complaints, medical enquiries, assessment reports from regulatory etc
- Local management/oversight of risk minimisation measures activities related to urgent safety restrictions and emerging safety issues
Ogłoszenie Archiwalne
Ogłoszenie Archiwalne
Deputy EU Qualified Personnel of Pharmacovigilance (Deputy EU QPPV)
Warszawa
Wygasła: 20.04.2019
Specjalista
Ogłoszenie Archiwalne
Ogłoszenie Archiwalne
Medical Information Specialist
Warszawa
Wygasła: 20.04.2019
Specjalista
Ogłoszenie Archiwalne
Ogłoszenie Archiwalne
Qualified Personnel of Pharmacovigilance (QPPV)
Warszawa
Wygasła: 29.06.2018
Specjalista
Ogłoszenie Archiwalne
Ogłoszenie Archiwalne
Starszy Specjalista ds. Badań Klinicznych
Warszawa
Wygasła: 15.09.2015
Specjalista
Ogłoszenie Archiwalne
Ogłoszenie Archiwalne
