Posted on May 18, 2020 by eTeam Inc.
Amsterdam, Noord-Holland, Netherlands
Title: QPPV Manager
Location: NL (work from home)
- Should have good reading, writing & verbal communication skill.
- Ability to learn quickly is a must.
- should have understanding of clinical product life cycle.
- Focus on quality and customer service.
- Should be good in Microsoft office suite (outlook, word, excel etc.).
- Knowledge of information resources and the effective/efficient use of them
- Understanding of medical concepts and the implications on a broader scale in the Pharmaceutical industry (regulatory, PV, legal, commercial, drug development, etc.)
- Experience in Medical Information/Communications in the Pharmaceutical Industry (or related Medical Affairs role)
- Responsible for the teams within QPPV Office and PV Training.
- Provide strategy, vision, development and management of relevant supportive or operational staff in area.
- Oversees the area of Quality and Compliance resources, as well as the LSO function.
- Reviews and approves all Standard Operating Procedures (SOPs) pertaining to the post marketing PV function and related activities at Wipro as appropriate.
- Provides (and/or delegate) internal/client training on the principles of safety including but not limited to the functions, mentioned above, and ensure consistent use of PV terminology and reference to PV legislation to ensures the continues development of a compliant department.
- Present (as speaker, round-table facilitator, etc.) at external PVG conferences when suitable opportunities arise.
- In cooperation with the Corporate Quality responsible to ensure that outcomes from PV audits related to the post marketing setting are properly monitored, that a quality management system (QMS) is in place to monitor the progression of PV Deviations and PV Corrective and Preventive Action plans (CAPAs) as well as status on PV audit and Inspections for relevant clients/sponsors.
- Lead relevant PV and Change management processes and projects related to PV area.
- Ensures appropriate resources are available to support the various roles in the area.
- May act as QPPV or Deputy QPPV in accordance with the JD for these function, and for allocated clients, acts as a single point of contact for the Regulatory Authorities on a 24-hour basis in the function as a QPPV
- Overall contact point for PVG Audit and inspections within the area, and provides input to the planning of internal or client audits of Pharmacovigilance and remains knowledgeable of the status of the audit plan. Reviews the findings from audits and inspections of all functions, which are pertinent to the QPPV role (or delegate to the assigned QPPV for project) and ensure corrective measures are investigated as appropriate. This is done in cooperation with corporate quality allocated staff.
- Oversees that the Wipro post marketing PV services is up-to-date and according to legislation
- B-Pharm/Life sciences graduate
- 8-10 years Pharma or CRO exp
- English + Local Language