Manager, Drug Safety Systems Support
Proclinical is currently recruiting for a Manager of Pharmacovigilance Systems Support for a biopharmaceutical company located in Cambridge, MA. Successful candidate will be the primary liaison between the manages services team and the PV department including the PV vendor. This role will support the Drug Safety team with technical questions regarding the safety database and the PVQ reporting tool.
- Act as the liaison between the managed services team, PV and the safety vendor.
- Create and/or modify PVQ reports to support compliance, vendor oversight, audit requests and health authority inspections.
- Support DSPV with creating reports in PVQ as needed.
- Develop and maintain process documents that describe the purpose and working instructions for all PVQ reports.
- First line of support for Argus or PVQ questions or issues and escalate issues as needed to managed services.
- Responsible for tracking all managed service tickets and ensuring timely and adequate follow-up from the support vendor.
- Assist with purchase order reconciliation from managed services.
- Work with managed services to support PV request for database and/or PVQ changes.
- Participate in UAT testing as needed for any PV system.
- Perform routine regulatory intelligence activities related to changes in global reporting requirements or any change impacting PV systems.
- Support the PV team with MedDRA and WHO Drug Dictionary updates.
- Collaborate with PV operations to ensure that all study start up activities related to the safety database are configured properly.
- Accountable for reconciliation activities between Global Patient Safety and Post Marketing programs to ensure reporting of all adverse event data.
- Support DSPV business owner responsibilities for other AE/PC reporting tools.
- Maintain knowledge of adverse event reporting process and the safety system and contributes to the development, improvement and standardization of new processes and methods.
- Undertake activities necessary to support and maintain a state of inspection readiness.
- Support the quality review of SAEs and SUSARs following data entry by vendor.
Skills and Requirements:
- Bachelor's degree in nursing, pharmacy, or other health care related profession or life sciences required
- Master's degree in health care related profession preferred, but not essential
- 5-7 years of direct "hands on" Drug Safety and Pharmacovigilance experience
- Vendor management experience
- Knowledge of FDA, ICH, EU Regulations and Requirements for Pharmacovigilance
- Experience using ARISg, Argus or other Safety Database applications required
- Working knowledge of PVQ
- Previous experience with data visualization tools, preferred
- Strong analytical and problem-solving skills with excellent attention to detail
- Strong verbal, written technical communication and presentation skills
- Proficiency in standard desktop software programs (Word, Excel, Outlook)
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.