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Randstad Sr Pharmacovigilance Process Manager in Cambridge, Massachusetts

Sr Pharmacovigilance Process Manager

job details:

  • location:Cambridge, MA

  • salary:$72.74 - $85.57 per hour

  • date posted:Thursday, March 26, 2020

  • experience:7 Years

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:31625

job description

Sr Pharmacovigilance Process Manager

job summary:

As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

location: Cambridge, Massachusetts

job type: Contract

salary: $72.74 - 85.57 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

  • 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

qualifications:

  • 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.

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