Replimune, Inc.
Director, Pharmacovigilance Systems
Replimune, Inc. - Woburn, Massachusetts, us, 01813
Work at Replimune, Inc.
Overview
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Overview
Overview
Summary of job description:
The Director, Pharmacovigilance Systems (PV Systems) will report to the VP, Global Drug Safety & Risk Management. The Director, Pharmacovigilance Systems manages the relationship and oversight of technology service providers, vendors, and business stakeholders. This position is also responsible for the delivery of systems, configuration and associated validation activities of Pharmacovigilance systems, and fulfillment of data change requests.
The Director, Pharmacovigilance Systems will also participate in other department and cross-functional meetings with IT, Clinical, Regulatory, etc., as well as other intra and/or inter-departmental activities and initiatives.
Responsibilities
Responsible for querying, retrieving, and organizing data as requested by various stakeholders from the safety database. Responsible for producing weekly, monthly, and ad hoc metric reports to support PV activities. Managing relationship with PV vendors regarding IT systems and services, including maintaining and updating system configurations in accordance with applicable procedures and regulations. Investigating, negotiating, managing, and implementing potential internal safety solutions for Replimune. Collaborate with internal stakeholders - including IT and business resources, contracts, and procurement - to develop criteria and best practices for vendor selection. Managing IT Budget for Global Drug Safety and Pharmacovigilance Systems. Evaluating, communicating, and mitigating potential risks. Participating in PV audits and inspections as an SME and providing reports as needed. Participating in PV vendor oversight activities such as vendor meetings. Other responsibilities: Other responsibilities as assigned Qualifications
Bachelor's degree in the life sciences or related will be considered with applicable job experience. 8+ years of experience or the equivalent combination of education and experience. Experience and skill requirement: Experience in safety database applications (specifically, Argus Safety). Experience creating PV reports for aggregate reporting, reconciliation, and signal detection. Well versed in data migration, application configurations, MedDRA and WHO Drug dictionary implementation. Proficient in authoring and reviewing of PV documents. Experience in vendor management, specific to safety systems. Experience in safety vendor selection and negotiation. Knowledge of PV regulatory reporting requirements. Ability to multi-task in a high-paced, fast-moving environment with changing priorities. Solid written and oral communication skills. Detail and solution-oriented, able to think outside the conventional "Big Pharma" mentality, and comfortable working in a small company/biotechnology environment. Able to work both independently and in a team environment. Proficient in standard computer software (Word, Excel, and Power Point). Physical Requirement: Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment. Knowledge of GCPs, GVP, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.
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Summary of job description:
The Director, Pharmacovigilance Systems (PV Systems) will report to the VP, Global Drug Safety & Risk Management. The Director, Pharmacovigilance Systems manages the relationship and oversight of technology service providers, vendors, and business stakeholders. This position is also responsible for the delivery of systems, configuration and associated validation activities of Pharmacovigilance systems, and fulfillment of data change requests.
The Director, Pharmacovigilance Systems will also participate in other department and cross-functional meetings with IT, Clinical, Regulatory, etc., as well as other intra and/or inter-departmental activities and initiatives.
Responsibilities
Responsible for querying, retrieving, and organizing data as requested by various stakeholders from the safety database. Responsible for producing weekly, monthly, and ad hoc metric reports to support PV activities. Managing relationship with PV vendors regarding IT systems and services, including maintaining and updating system configurations in accordance with applicable procedures and regulations. Investigating, negotiating, managing, and implementing potential internal safety solutions for Replimune. Collaborate with internal stakeholders - including IT and business resources, contracts, and procurement - to develop criteria and best practices for vendor selection. Managing IT Budget for Global Drug Safety and Pharmacovigilance Systems. Evaluating, communicating, and mitigating potential risks. Participating in PV audits and inspections as an SME and providing reports as needed. Participating in PV vendor oversight activities such as vendor meetings. Other responsibilities: Other responsibilities as assigned Qualifications
Bachelor's degree in the life sciences or related will be considered with applicable job experience. 8+ years of experience or the equivalent combination of education and experience. Experience and skill requirement: Experience in safety database applications (specifically, Argus Safety). Experience creating PV reports for aggregate reporting, reconciliation, and signal detection. Well versed in data migration, application configurations, MedDRA and WHO Drug dictionary implementation. Proficient in authoring and reviewing of PV documents. Experience in vendor management, specific to safety systems. Experience in safety vendor selection and negotiation. Knowledge of PV regulatory reporting requirements. Ability to multi-task in a high-paced, fast-moving environment with changing priorities. Solid written and oral communication skills. Detail and solution-oriented, able to think outside the conventional "Big Pharma" mentality, and comfortable working in a small company/biotechnology environment. Able to work both independently and in a team environment. Proficient in standard computer software (Word, Excel, and Power Point). Physical Requirement: Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment. Knowledge of GCPs, GVP, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.
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