KEY RESPONSIBILITIES:
* Support the PV QMCM in ensuring that detailed systems and procedures are in place in accordance with Group Policies and Group PV Policies and relevant guidelines of external regulatory and professional organizations.
* Monitor Key Performance Indicators (KPIs) for EME PV activities.
* Identify trends with respect to non-compliance with KPIs; document and investigate with input from relevant team and PV QMCM.
* Compile monthly PV Global Report, QPPV compliance Report and ad-hoc compliance reports highlighting any non-compliances to KPIs / procedures.
* Coordinate the monitoring of Group PV, PV Partner and Service Provider compliance with written agreements (e.g. Safety Data Exchange Agreements, PV Agreements) as per the relevant procedures.
* Draft, circulate and follow-up on Vendor Complaints as per relevant procedures.
* Perform periodic vendor assessments in conjunction with QA and other departments for PV and shared vendors
* Assist deviation investigations and CAPA proposals, where required.
* Follow-up on all open PV Partner or Service Provider CAPAs from audits and deviations.
* Perform reconciliation activities for EME vendors and partners.
* Maintain a compliant and accurate XEVMPD for Aspen ensuring excellent tracking, input of data, review and management of XEVMPD submissions ensuring the defined timelines by EMA are met. Support the implementation of the IDMP requirement.
* Support with PSMF maintenance, when necessary, by ensuring change control, update and completion of approval is achieved by the defined timelines.
* Managing PV email mailboxes by triaging, flagging, actioning, forwarding and/or closing/archiving.
* Support PV colleagues with presenting, chairing and/or minuting team meetings.
* Ensure knowledge of responsibilities regarding pharmacovigilance, in line with EU legislation and guidelines.
* Keep abreast of developments in best practice, inspection trends and all QMS related activities.
OTHER RESPONSIBILITIES:
* Compliance with relevant Aspen Pharma Trading Limited, EME and Aspen Group policies, SOPs and guidelines.
* Awareness of Aspen Pharma Trading Limited and EME Pharma Affairs KPIs, Goals and Objectives.
* Work towards the continuous development and improvement of the department.
* Work effectively and efficiently.
* Execute other duties as may be required by management, as training & experience allows.
* Strive to uphold Aspen Group core values.
* Adherence to Company Health & Safety procedures
* Participate in training programmes.
* Any other duties as assigned by your Manager.
Education and Knowledge
* Life Sciences or Pharmacy degree.
* 2 plus years' experience in Pharmacovigilance / Quality Management Systems
* Deviation and CAPA experience (writing/review)
* Audit and Self-Inspection (Participation/CAPA Report Response)
* Written procedures (SOP/WIs Writing or Peer Review)
* Information gathering, monitoring and report writing.
* Projects (advantage).
* Decision making.
* Attention to detail.
* Problem solving.
LD