Randstad Sr Pharmacovigilance Process Manager in Cambridge, Massachusetts
Sr Pharmacovigilance Process Manager
salary:$72.74 - $85.57 per hour
date posted:Thursday, March 26, 2020
industry:Professional, Scientific, and Technical Services
Sr Pharmacovigilance Process Manager
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location: Cambridge, Massachusetts
job type: Contract
salary: $72.74 - 85.57 per hour
work hours: 9 to 5
Interacts and communicates effectively internally and cross-functionally in a highly matrix environment.
Responsible for the implementation and management of effective structure, procedures and tools to ensure aggregate report and other functional deliverables are completed with high quality
Responsible for strategic oversight of aggregate safety reports for investigational and marketed products
Collaborates with Global Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs, Finance, Safety Statistics, etc) contributing to aggregate safety reports
Manages distribution of assignments and prioritization of tasks within the Pharmacovigilance operations aggregate reporting team
Manages resource planning and ensures adequate support from internal team and vendor team to deliver all scheduled safety reports.
Manages commitments with license partners to ensure both meet aggregate reporting requirements as per the PV Agreement between companies.
Provides strategic oversight of Vendor and manages both quality and compliance of assignments, including training and mentoring when appropriate
Oversee functional specifications of any data requirements for aggregate deliverables from the Global safety database and analytics team
Responsible for maintaining compliance metrics and contributes to implementation of Corrective Action and Preventive Action (CAPA) for non-compliance findings
Support continuous improvement/quality system initiatives
Assist in preparation and support of audits and inspections
Liaises with Regulatory Affairs to coordinate synchronization of aggregate reports
Establishes and chairs document working groups comprised of authors and subject matter experts (SMEs) from the project or product teams, as necessary
Bachelors required. Degree in scientific/medical field or advanced degree preferred
Minimum 8 years pharmaceutical or health care related industry experience required; previous experience working in global environment preferred.
Minimum 5 years' experience in Pharmacovigilance with experience in preparation and submission of periodic aggregate safety reports.
Minimum 3 years experience working with CROs, vendors, and relationship management preferred.
Excellent organization skills and ability to prioritize individual and team work loads
Expert knowledge of Global regulatory requirements
Experience in vendor management for outsourced activities
Ability to work in a dynamic environment and manage competing priorities
Understand safety data capture in clinical trials and post marketing settings
Good written and verbal communication skills
Ability to work under strict deadlines and changing priorities with minimal supervision
Excellent negotiation, conflict resolution, decision making, problem solving and critical thinking skills
Experience with and demonstrated success in working on cross-functional diverse teams required
Ability to interpret, analyze and clearly present scientific and technical data
Scientific / medical writing (including word processing and data presentation packages (i.e. Word, Excel)
Ability to thrive in a global matrix environment
Experience with aggregate analysis and writing PSUR's, PADERs and DSUR.
Knowledge of case processing and aggregate reporting requirements.
Demonstrated proficiency with computer applications and understanding of safety data.
Knowledge of pharmaceutical business, including drug development and regulatory aspects.
Knowledge of US, EU and international regulatory/safety regulations and guidelines.
Fluency in oral and written English.
skills: Pharmacovigilance, MS-WORD, CAPA, MS-EXCEL, DSUR (Development Safety Update Report), Regulatory Affairs Operations, PSUR (Periodic Safety Update Report)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.