Local Contact Person Pharmacovigilance (LCPPV) - Freelance - PT Poland
Aktuelle Original-Stellenanzeige
Quelle: StudySmarter Stellenbestand · Status: aktiv · Bewerbung über das zentrale StudySmarter-Formular.
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Das ist der Job
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Darum lohnt es sich
Main responsibilities Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally required Monitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning client products or product classes Monitors and maintains awareness of changes to local legislation pertaining to pharmacovigilance Supports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if needed Performs local literature screening and collection of safety information Assists on the development or the review of the local pharmacovigilance system master file (LPSMF), if required Supports local signal detection, if applicable Manages local risk minimization measures, as applicable Reports to and maintains regular communication with the EU QPPV Supports the review of local PV agreements, if requested Performs local PV training to sales force, affiliate personnel, distributors Provides monthly activity report on status of local PV system Requirements University degree, preferably in medicine, pharmacy or life sciences and minimum 2 years of experience in the performance of pharmacovigilance post‑marketing activities Have up‑to‑date knowledge of applicable global and local regulatory requirements In‑depth knowledge of the pharmacovigilance legal framework in the country where LCPPV services are delivered Fluency in the written and spoken English language Reside in the country where LCPPV provides services, if required Benefits Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/office‑based working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft‑skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers *Office‑based employees are required to work in‑office no less than two (2) days per each work week.
There are certain positions for which employees are required to work in‑office no less than three (3) days per each work week for employees within reasonable distance from one of our global offices. “The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”).
The role The Local Contact Person for Pharmacovigilance (LCPPV) coordinates and performs the logistical aspects of pharmacovigilance activities in post-marketed programs to ensure compliance with local requirements. This position controls and monitors operational pharmacovigilance activities and may back‑up Pharmacovigilance Manager(s) as required.
Allucent does not accept unsolicited resumes from third‑party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third‑party recruitment agency.
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