Pharmacovigilance Manager
WarszawaPharmacovigilance Manager
Warszawa
NR REF.: 1148538
Your responsibilities:
Warszawa
NR REF.: 1148538
Your responsibilities:
- Supporting the QPPV in the fulfilment of GVPs and legal requirements.
- Supporting the QPPV in the management of the company PV System.
- Representing the local reference contact point for the national CA (when requested)
- Ensuring the business continuity from PV perspective
- Maintaining the oversight of the local PV activities and processes, including the relevant quality system, and ensuring availability and effectiveness of a local PV Business Continuity Plan, according to Global and Local SOPs
- Maintaining the QPPV constantly informed on PV activities through the monthly report
- Maintaining the QPPV constantly informed on local safety issues, new/updated local PV requirements and/or rules
- Maintaining the back-up person (Deputy) constantly informed, and informing QPPV in case of activation of back-up procedure
- Collection, management and prompt transmission to HQ PV, of case reports occurred in the Territory and arising from any source, and submission to the Competent Authority (when applicable)
- Collection and transmission to the HQ PV of local safety information and sales data for the preparation of PSURs, DSURs, RMPs and ACOs and the relevant submission to the Competent Authority (when applicable)
- Performing local signal detection and monitoring patterns of use
- Performing local literature search;in case of interventional studies, ensuring the transmission of clinical studies information/documentations to the QPPV/HQPV
- Revision of SDEA and defining and/or reviewing service/technical agreements (when applicable);
- Forwarding national CA requests to HQPV and QPPV and supporting them for any safety action/risk minimization measures to be implemented;
- Forwarding national CA inspection notification and external partners audit notification to HQ R&D QA and QPPV
- Ensure adequate PV training of the PV personnel, non-PV personnel and service/technical providers involved in PV processes, maintaining the awareness of the relevant status;
- Ensuring, in collaboration with the Local QA, that the Local PV SOPs cover all PV local processes and that they are in compliance with the legal rules and global SOPs;
- Ensuring, in collaboration with the Local QA, that the local PV deviations are collected, managed and relevant CAPA identified and implemented, communicating any significant local deviation and identified Global deviations to HQ R&D QA and QPPV;
- Collecting pharmacovigilance performance information for the transmission to HQ R&D QA and QPPV;
- Maintaining and archiving PV relevant records
- Developing a positive image of oneself and the Company by involvement, co-operation and initiation of constructive solutions.
- University degree (medical or related is preferred).
- At least 3-year experience at a similar position in the pharmaceutical industry
- Very good knowledge of the MS Office suite and the MedDRA reporting module
- Very good oral and written knowledge of English (B2+/C1)
- Systemic approach to work
- Impeccable manners
- Employment contract
- Medical Insurance
- Multisport card
- Life insurance
- Flexible working hours
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
