PV Officer Oversight (m/w/d) (PR-34065550)

Für einen unserer Kunden aus der Pharma-Welt sind wir aktuell auf der Suche nach freiberuflicher Unterstützung in der Rolle als

PV Officer Oversight (m/w/d)

idealerweise mit 5+ Jahren Erfahrung im Bereich Pharmakovigilanz auf lokaler sowie globaler Ebebe

Parameter:

• Start: ab 01.04.2023
• Laufzeit: 1 Jahr
• Auslastung: Vollzeit (mind. 30h/Woche)
• Standort: remote

Aufgaben:

• Act as the key contact point for Safety Officer in the countries of responsibility
• Support/educate Safety Officers in the countries of responsibility in the implementation of PV relevant processes on country level
• Support/educate the Safety Officer in regards to management of audits and inspection, including the definition, handling and closing of audit/inspection action items / findings as well as CAPAs management in collaboration with PVRQA and local subject Matter Experts.
• Support/educate interfacing functions in the affiliates having relevance for the the company's PV System, in the implementation of GVP compliant processes
• Ensure effective two-way communication with the Safety Officer Network for timely responses and communication
• Run and manage onboarding process for new SOs including admin tasks
• Support the development, review, implement relevant Safety Officer and procedural documents in order to meet local and international regulatory requirements in PV reporting and quality control/compliance.
• Support PV Regions projects in PV, PV education programs, change management
• Development and implementation of processes and KPIs to measure Pharmacovigilance compliance in the countries (affiliates as well at 3rd parties fulfilling PV tasks for the company) and the definition of CAPAs in case of incompliances