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AD, Aggregate Reporting (Pharmacovigilance)

  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: Negotiable
  • Job reference: 368031/003_1567550588
  • Sector: Safety, EPM Scientific
  • Date posted: 03/09/2019

AD, Aggregate Reporting (Pharmacovigilance)

Greater Boston Area

A Top-10 pharmaceutical leader that focuses on developing and manufacturing world-class innovative medicines are currently seeking an AD, Aggregate Reporting (Pharmacovigilance) as their company is rapidly expanding! This company has received recognition for their overall success and is looking to increase headcount within the Pharmacovigilance department. Now is a pivotal time to get in with this group as AD, Aggregate Reporting (Pharmacovigilance) will have the ability to lead and impact their robust pipeline of promising new medicines.

The AD, Aggregate Reporting (Pharmacovigilance) will have the following responsibilities:

  • Provides leadership to regional aggregate reporting team including training, mentoring, development and appraisals

  • 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 global leadership and 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

  • Provides strategic and financial 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

The ideal candidate will have the following skill set:

  • 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.

  • Minimum of 2 years of line management or matrix management required

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