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about 1 month ago
Requirements and responsibilities
We’re building a local network of talented PV experts to collaborate with on future projects. We’d love to connect with professionals who are interested in staying in touch for freelance (parttime) opportunities. Let’s start the conversation and build a connection! Currently we are looking to add people to our network in Estonia, Latvia and Poland.The roleThe 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.Main responsibilities:Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally requiredMonitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning the client products or products classMonitors and maintains awareness of changes to local legislation pertaining to pharmacovigilanceSupports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if neededPerforms local literature screening and collection of safety informationAssists on the development or the review of the local pharmacovigilance system master file (LPSMF), if requiredSupports local signal detection, if applicableManages locally risk minimization measures, as applicableReports to and maintains regular communication with the EU QPPVSupports the review of local PV agreements, if requestedPerforms local PV training to eg. sales force, affiliate personnel, distributorsProvides monthly activity report on status of local PV systemWho are we looking for: University degree, preferably in medicine, pharmacy or life sciences and minimum 2 years of experience in the performance of pharmacovigilance post-marketing activitiesHave up-to-date knowledge of applicable global and local regulatory requirementsIn-depth knowledge of the pharmacovigilance legal framework in country where LCPPV services are deliveredFluency in the written and spoken English languageReside in the country where LCPPV provides services, if requiredAbout AllucentOur mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.Together we SHINE. Find more information about our values.Apply now!If you are interested in this role please apply through the button or for more information reach out to Yael Kokernoot, yael.kokernoot@allucent.comBenefitsBenefits of working at Allucent include:Comprehensive benefits package per locationCompetitive salaries per locationDepartmental Study/Training Budget for furthering professional developmentFlexible Working hours (within reason)Opportunity for remote/office-based* working depending on locationLeadership and mentoring opportunitiesParticipation in our enriching Buddy Program as a new or existing employeeInternal growth opportunities and career progressionFinancially rewarding internal employee referral programAccess to online soft-skills and technical training via GoodHabitz and internal platformsEligibility for our Spot Bonus Award Program in recognition of going above and beyond on projectsEligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employeesDisclaimers:*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”). 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. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
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