pharmacovigilance (pv)specialist - home based

• Support the International QPPV Office team in meetings, when require
• Set up meetings, prepare agendas and minutes, when required

• Management and implementation of change controls and actions plans for PV activities
• Management of periodic oversight meetings with local QPPVs and PV Partners
• Perform other Geographic Expansion-related activities, as appropriate

• 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 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. In addition, identify actions to be implemented in marketing authorisation transfer and/or withdrawal
• Support the review of PV agreements, highlighting where local PV requirements should be reflected within the agreements 

• Act as support or back-up for the preparation and ongoing maintenance of the PSMFs or equivalent documents, and the related documentation, in accordance with the assigned schedule
• 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

• Assisting with the readiness, preparation, facilitation and follow-up of PV audits and inspections
• Assisting with the development, management & implementation of corrective & preventative actions (CAPAs) arising from PV audits and inspection

• 1+ years of experience as Specialist in PV
• Academic background in pharmacovigilance, regulatory affairs or life science
• Strong organizational and communication skills.
• Willingness to learn and ability to manage multiple tasks in a dynamic environment.
• Proficiency in Microsoft Office tools; familiarity with budget tracking systems is a plus.
• Fluency in English, both written and spoken
• Ability to review service provider contracts, and work effectively with service providers.

La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad (https://www.randstad.it/privacy/) ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).