What are the responsibilities and job description for the Pharmacovigilance Project Manager position at The Fountain Group?
Currently I have an opening for a Pharmacovigilance Project Manager located in Cambridge, MA. Details for the position are as follows:
Job Description:
- Serve as a primary liaison and point of contact for vendor operations and vendor oversight, including vendors performing case management, case intake (i.e., Call Centers), scientific literature review, etc.
- Oversee operations performed by the PV BPO vendor including contract compliance, quality, and timeliness of deliverables.
- Serve as the primary liaison and point of contact for vendor operations including the PV BPO vendor and/or vendors performing case management, case intake, literature review, call centers.
- Provide Subject Matter expertise (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, legal case processing, vendor oversight, etc.
- Provide leadership and oversight on case management for the Global PV Operations Team to ensure adverse event information is processed according to company timelines and quality standards.
- Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to global Health Authorities, alliance partners, local operating companies (LOCs) including SUSAR and SAE communication to ECs and investigators as applicable.
- In partnership with the Global Standards and Compliance team, direct and manage communication with alliance partners, LOCs and CROs regarding the evaluation and processing of ICSRs.
- In partnership with the Global Standards and Compliance team, lead and direct the review and approval of alliance partner safety data exchange agreements for the inclusion of appropriate safety reporting requirements.
- Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, metrics, and monitoring of performance and compliance, and training at a global level.
- Minimum 4 years pharmaceutical or health care related industry experience required.
- Minimum 3 years PV experience with 1 year experience working with CROs, vendors, and relationship management required.
- Global experience with CROs, vendors and relationship management preferred.
Technical Information:
- Pay: $70-76 hourly, depending on experience level
- Onsite position, M-F, 8am-4:30pm
- 6-month contract, potential for extension/conversion
Salary : $70 - $76
