New job PV Compliance Specialist in Gaithersburg, MD #pharmacovigilance #ich #gxp #pharma - send resumes to dan.wienczkowski@rightthinginc.com

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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: PV Compliance Specialist in Gaithersburg, MD #pharmacovigilance #ich #gxp #pharma - send resumes to dan.wienczkowski@rightthinginc.com Dan Wienczkowski, ACIR, CIR, CDR, CSSR, PRC posted a job: PV Compliance Specialist in Gaithersburg, MD #pharmacovigilance #ich #gxp #pharma - send resumes to dan.wienczkowski@rightthinginc.com "Title: PV Compliance Specialist Location MD, Gaithersburg Description - Serves as a Pharmacovigilance Compliance resource for Patient Safety and the MedImmune Enterprise. - Responsible for monitoring, assessing, and interpreting global regulatory requirements related to MedImmune pharmacovigilance activities. - Participates in PV, GCP, and GMP audit/inspection activities including preliminary preparation and internal host support. - Liaise with appropriate personnel both internal and external to Patient Safety to develop or recommend corrective actions to audit/inspection findings and conduct follow up on documented actions - Conducts Internal Assessments of Patient Safety activities, documents, and associated records. - Performs trending on assessment findings to identify areas for process improvement or possible revisions to training requirements. - Leads activities during the creation/revision of Pharmacovigilance Agreements with MedImmune business partners. - Liaise with internal MedImmune legal/contract representatives as required. - Track and investigate late submissions to business partners, third parties, and regulatory authorities in collaboration with PV Operations. - Performs trending on root causes for late submissions to identify areas for process improvement or possible revisions to training requirements. - Participates in creation, review and revisions to standards (e.g., SOPs, Work Instructions) within Patient Safety and on behalf of the enterprise as required. - Performs Quality Control review of Patient Safety related aggregate reports. - Liaise with representatives from other MedImmune functional groups to maximize the effectiveness of PV Compliance activities enterprise wide. - Support Patient Safety functional groups (i.e., Operations, Safety Systems, Risk Management, and Safety Evaluation) to optimize departmental quality and compliance. Requirements: - BA/BS and/or advanced degree (preferably life science or related field) - Minimum 5 years pharmaceutical industry experience required with at least 3 years focused on pharmacovigilance compliance. - Demonstrated ability to apply principles, concepts and industry best practices governing patient safety in assigned projects and company deliverables. - Possess a working knowledge of global safety reporting activities, regulations, ICH/GXP guidelines, and be able to provide guidance regarding regulatory requirements. - Pharmacovigilance auditing experience is highly desired. - Willingness and ability to travel internationally. Please email your resume to - dan.wienczkowski@rightthinginc.com"

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