Qualified Person for Pharmacovigilance (QPPV - UK)
Posted 24 days ago
- London, Greater London
- Any
- External
- Expires In 2 months
Qualified Person for Pharmacovigilance (QPPV - UK)
Location: Harrow, Middlesex
This position is with our sister company Lambda Therapeutic Research Limited
The UK QPPV will act in compliance with Regulation (EU) No. 1235/2010 & 520/#####, Directive#####1/83/EC & 2010/84/EU, Applicable National Laws and EMA‘s Guideline on Good Pharmacovigilance Practices (GVP), MHRA Guidance on pharmacovigilance procedures and in accordance with the LAMBDA and MAH’s Procedures.
The Role
The UK QPPV will lead in the below activities:
Establishment, maintenance, and management of the Clients’ Pharmacovigilance system.
Oversees functioning of pharmacovigilance system in all relevant aspects including its quality management system (QMS), maintaining and improving its compliance with Health Authorities requirements.
Having awareness of any conditions or obligations adopted as part of the marketing authorisation and other commitments relating to safety surveillance or the safe use of the product including risk management.
Act as a single contact point for MAH and the competent authorities with 24/7 availability.
The QPPV is reporting to the Head of QPPVs at Lambda Therapeutic Research Limited, providing oversight of his tackled clients’ pharmacovigilance system management strategies.
Ensuring oversight via monitoring and Fulfilment the operational responsibilities by ensuring effective Interface with other cross functional stakeholders including pharmacovigilance Quality Assurance, Pharmacovigilance operations including Medical Information for all ongoing activities.
Oversees preparation and maintenance of pharmacovigilance system master file (PSMF)
Maintain and improve compliance of the clients PV system in line with the Health Authorities legal requirements, ensuring accurate and up to date reflection of the PV system.
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 via monitoring Risk – Benefit profile of the clients’ products. Signal detection and evaluation of trends and safety signals from any source.
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 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.
Supporting pharmacovigilance operations teams for the compliance of ongoing activities regarding Safety cases and aggregate reports managements.
Review of all client’s relevant documents including SLA, Pharmacovigilance Management Plan (PMP), Safety data exchange Agreements (SDEA).
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.
Representing the client during pharmacovigilance inspection conducted by Health Authority and internal audits as applicable. Manages/provides support during Clients Audits and inspections conducted by regulatory authorities.
Reviewing Audit, inspection reports and the relevant corrective and preventive actions (CAPA) plan.
Overseeing the training management system (TMS) and the training plans. Ensures that global and local personnel, including clients’ representatives are complying with the required training plans and training records are maintained.
Ensures effective interface with Business development and financial department in optimizing development projects in line with Lambda’ strategy and budget. Reviewing requests for proposals (RFPs) and provide his feedback regarding cost estimation and proposal feasibility.
The Person
Life-science degree (Medical Degree, MD preferable), pharmacy, nursing, life science or related discipline.
Previous working experience as an QPPV, or deputy is desired.
Significant experience in pharmacovigilance including a thorough understanding of safety science and other pharmacovigilance processes. Previous experience as deputy QPPV is preferred but not required.
Expertise in Global pharmacovigilance regulations, such as EMA regulations, GVP, ICH Guidelines and other applicable regulatory guidance documents including regulations which govern responsibilities of Local Responsible Person in Poland.
Demonstrated strong leadership and managerial capability.
Strong English skills (written and spoken).
Project management skills and ability to maintain timelines.
People management skills and ability to interact with staff at various levels and in various functional areas.
Highly process driven with excellent attention to detail and ability to priorities effectively.
Demonstrated ability to solve problems along with strong organizational skills.
Good computer skills required to develop high level of understanding of Company Safety databases and proficiency in database management and information sourcing.
What we offer:
International and dynamic working environment.
Employment based on an employment contract.
Opportunity to grow professionally.
Attractive benefits package.
How to apply:
If you are interested, please send your CV with a cover letter by
5th Jun#####24 .
A bit about us:
Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Toronto (Canada), Pittsburgh (USA) and Las Vegas (USA) with approxima#####500 employees across the globe. Lambda offers full spectrum clinical trial solutions and pharmacovigilance services empowered by more than 20 years of service to the biopharmaceutical and generic industry.
Location: Harrow, Middlesex
This position is with our sister company Lambda Therapeutic Research Limited
The UK QPPV will act in compliance with Regulation (EU) No. 1235/2010 & 520/#####, Directive#####1/83/EC & 2010/84/EU, Applicable National Laws and EMA‘s Guideline on Good Pharmacovigilance Practices (GVP), MHRA Guidance on pharmacovigilance procedures and in accordance with the LAMBDA and MAH’s Procedures.
The Role
The UK QPPV will lead in the below activities:
Establishment, maintenance, and management of the Clients’ Pharmacovigilance system.
Oversees functioning of pharmacovigilance system in all relevant aspects including its quality management system (QMS), maintaining and improving its compliance with Health Authorities requirements.
Having awareness of any conditions or obligations adopted as part of the marketing authorisation and other commitments relating to safety surveillance or the safe use of the product including risk management.
Act as a single contact point for MAH and the competent authorities with 24/7 availability.
The QPPV is reporting to the Head of QPPVs at Lambda Therapeutic Research Limited, providing oversight of his tackled clients’ pharmacovigilance system management strategies.
Ensuring oversight via monitoring and Fulfilment the operational responsibilities by ensuring effective Interface with other cross functional stakeholders including pharmacovigilance Quality Assurance, Pharmacovigilance operations including Medical Information for all ongoing activities.
Oversees preparation and maintenance of pharmacovigilance system master file (PSMF)
Maintain and improve compliance of the clients PV system in line with the Health Authorities legal requirements, ensuring accurate and up to date reflection of the PV system.
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 via monitoring Risk – Benefit profile of the clients’ products. Signal detection and evaluation of trends and safety signals from any source.
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 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.
Supporting pharmacovigilance operations teams for the compliance of ongoing activities regarding Safety cases and aggregate reports managements.
Review of all client’s relevant documents including SLA, Pharmacovigilance Management Plan (PMP), Safety data exchange Agreements (SDEA).
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.
Representing the client during pharmacovigilance inspection conducted by Health Authority and internal audits as applicable. Manages/provides support during Clients Audits and inspections conducted by regulatory authorities.
Reviewing Audit, inspection reports and the relevant corrective and preventive actions (CAPA) plan.
Overseeing the training management system (TMS) and the training plans. Ensures that global and local personnel, including clients’ representatives are complying with the required training plans and training records are maintained.
Ensures effective interface with Business development and financial department in optimizing development projects in line with Lambda’ strategy and budget. Reviewing requests for proposals (RFPs) and provide his feedback regarding cost estimation and proposal feasibility.
The Person
Life-science degree (Medical Degree, MD preferable), pharmacy, nursing, life science or related discipline.
Previous working experience as an QPPV, or deputy is desired.
Significant experience in pharmacovigilance including a thorough understanding of safety science and other pharmacovigilance processes. Previous experience as deputy QPPV is preferred but not required.
Expertise in Global pharmacovigilance regulations, such as EMA regulations, GVP, ICH Guidelines and other applicable regulatory guidance documents including regulations which govern responsibilities of Local Responsible Person in Poland.
Demonstrated strong leadership and managerial capability.
Strong English skills (written and spoken).
Project management skills and ability to maintain timelines.
People management skills and ability to interact with staff at various levels and in various functional areas.
Highly process driven with excellent attention to detail and ability to priorities effectively.
Demonstrated ability to solve problems along with strong organizational skills.
Good computer skills required to develop high level of understanding of Company Safety databases and proficiency in database management and information sourcing.
What we offer:
International and dynamic working environment.
Employment based on an employment contract.
Opportunity to grow professionally.
Attractive benefits package.
How to apply:
If you are interested, please send your CV with a cover letter by
5th Jun#####24 .
A bit about us:
Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Toronto (Canada), Pittsburgh (USA) and Las Vegas (USA) with approxima#####500 employees across the globe. Lambda offers full spectrum clinical trial solutions and pharmacovigilance services empowered by more than 20 years of service to the biopharmaceutical and generic industry.
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