Pv Senior Specialist Hybrid

2 weeks ago

London, Greater London, United Kingdom PE Global Full time
Responsible for adverse event management including aggregate and ICSR health authority submissions and compliance monitoring.

Responsible for PV activities which may include but are not limited to:

PV intake, management and negotiation of local PV agreements,local due diligence activities, participation in audits and inspections and related readiness activities,review of local initiatives for compliance with PV requirements, SOP management, local training, communication of safety issues, people development,special projects as assigned and is able to work on these delegated activities independently.


Role:

  • Responsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties
  • Serves as SME and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.
  • Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy 01: Patient Safety.
  • Participates in and supports audits of contractual partners/vendors as necessary.
  • Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reporting countries covered by the country operation.
  • Assists in developing and maintaining local procedures (in compliance with regional and global standards), to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
  • Supports PV Lead in maintaining the local PV Training matrix and onboarding plans as assigned.
  • Supports the development and maintenance of local PV controlled documents (e.g., Company Core Pharmacovigilance Documents, training materials, etc. as applicable) ensuring that they are kept current.
  • Conducts and/or supports PV selfinspections as required by PV Legislations (where applicable).
  • Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
  • Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.
  • Supports training of local company staff, distributors, vendors, and business partners and can provide training as applicable.
  • May be responsible for Health Authority Website Monitoring for potential safety issues, safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation (as applicable).
  • May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with business partners, vendors and Alliance Managers as required, performing local qualification/due diligence activities, compliance reviews,and ensuring maintenance of the business partner data tracking system.
  • May be responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements,as applicable.
  • As assigned by PV Lead, responsible for scheduling and coordinating submission activities for PSURs and other Aggregate Reports to the local Health Authority in compliance with company procedures and local legislation (as applicable).
  • As assigned by PV Lead, responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures, and Additional Risk Minimization Measures locally as per department policy and ensures compliance with local legislations.
  • As assigned by PV Lead, prepare/maintain/submit local RMPs to the local HA (as applicable).
  • Responsible for filing, storage and archiving of safetyrelated documentation in accordance with company's policies and local requirements.

Requirements:

  • Health, life science, or medical science degree or equivalent by education/experience
  • Experience in the pharmaceutical industry is required (minimum 3 years)
  • Indepth knowledge of AE reporting requirements and relevant PV regulations, PV quality management systems and be an expert in PV?processes and activities.
  • Experience with PV audits and/or PV Health Authority Inspections
  • Ability to interface broadly?with colleagues within related functions and crossfunctionally and be able to work independently with no supervision except in the most complex of situations.?

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