Pharmacovigilance Database Specialist
4 settimane fa
Randstad Italy, for a client company in the pharmaceutical sector, is looking for a
Pharmacovigilance Specialist
Working Hours: full time.
Location: remote working.
The role of Pharmacovigilance (PV) specialist supports the International QPPV (Qualified Persona for Pharmacovigilance Office team to promote, maintain, and improve with the applicable regulatory and legal pharmacovigilance obligations in the EU and in International Territories where the Company operates.
The role acts ad the kay liaison point between the Company and the external contracted pharmacovigilance services providers, providing day-to-day operational support for PV system oversight assisting in collecting information on Countries, Affiliates, and PV Partners to support global expansion activities and supporting collaboration with Global Regulatory Affairs and Drug Safety colleagues to align global expansion activities and local QPPVs with PV requirements.
provides support to Geographic Expansion activities to: management and implementation of change controls and actions plans for PV activities, management of periodic oversight meetings with local QPPVs and PV Partners;
serves as back-up for the PV intelligence Coordinator to: support the maintenance of processes to ensure compliance with worldwide PV regulatory and legal requirements and to address any necessary changes in a timely and appropriate manner;
assist in coordinating the ongoing standard PV intelligence process;
promote awareness and contribute to continuous improvement of the PV intelligence process;
perform basic ad-hoc PV intelligence searches to support Geographic Expansion;
assist in identifying actions to be implemented in the marketing authorisation pre-submission phase and following post-marketing authorization approval based on local PV requirements including but not limited to local Pharmacovigilance System Master File (PSMF), local Qualified Person Responsible for Pharmacovigilance (QPPV), local Risk Management Plan/periodic reports. help maintain the schedule of updates and data requirements for the PSMFs or equivalent documents;
ensure the content of the PSMFs, or equivalent documents, are compliant vs GVP Module II requirements by liaising with key contributors from all relevant global functions and/or with the Local applicable PV regulations;
ensure the content of the PSMFs, or equivalent documents, are provided in a timely manner, collating the data, resolving queries and ensuring review, approval and release of the document as appropriate and per applicable procedures;
1+ years of experience as Specialist in PV;
~ Academic background in pharmacovigilance, regulatory affairs or life science;
~ Proficiency in Microsoft
The search is open to both male and female candidates (L.Please read the privacy policy pursuant to Article 13 of Regulation (EU) 2016/679 on data protection (GDPR) at
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