Randstad Pharmacovigilance Director in Cambridge, Massachusetts

Pharmacovigilance Director

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job details:

  • location:Cambridge, MA

  • salary:$1 per hour

  • date posted:Tuesday, September 12, 2017

  • job type:Temporary

  • reference:S_567463

  • questions:tim.heffernan@randstadusa.com617-679-7000

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Job Title: Pharmacovigilance Director

Location: Cambridge, MA

Hours; Standard business hours, Monday-Friday

Temporary assignment to start, ideally look to have candidate convert

Interface with commercial and other functions responsible for Patient Support / Assistance Program (PSP/PAP), Market Research Programs (MRP) and Real-World Evidence (RWE) Program development, initiation and termination/completion to support compliance with both internal standards and global regulatory requirements. Responsibilities involve developing relationships, maintaining relationships with other functions within the company with other parts of company that collect PV data

The goals for the role would be to work with these other functions and legal to ensure appropriate and relevant template language

Ensure availability of current program information for regulatory purposes including the Pharmacovigilance System Master File (PSMF)

Working hours: 8-5


  • Liaise with Global Safety Leads, others within GPSE, Drug Safety Officers in Local Operating Companies, Legal, and Commercial business units as applicable

  • Represent GPSE (internal and external-facing) as the SME regarding governance of PSP/MR/RWE programs from a pharmacovigilance perspective, including internal audits and regulatory inspections

  • Collaborate with and oversee vendors regarding delegated / outsourced tasks

  • Seek opportunities for process enhancement and efficiency

  • Develop / maintain process documents and templates

  • Develop / maintain materials for associated internal and vendor pharmacovigilance training

  • Facilitate and support adherence with the quality plan

  • Ensure the collection of appropriate metrics for quality and compliance monitoring and reporting to the Head of QA, Head of GPSE and the commercial business units

  • Escalate issues appropriately to senior management in GPSE and other involved functions

  • Minimum of 5 years pharmacovigilance experience; prefer 3 years direct experience with PSPs/PAPs, MRPs and/or RWE programs

  • Minimum of 2 years experience with vendor relationships

  • Excellent communication skills

  • Ability to work and collaborate cross-functionally

  • Understanding of business needs and strategies of commercial functions in the industry

  • Critical thinking and analytical skills

  • Experience with databases (safety and other) and with providing business requirements for data outputs

  • Good negotiation skills

  • Good knowledge of PV regulations relating to programs under area of accountability

  • Good computer literacy skills

  • Attention to detail

  • Excellent written and presentation skills

  • Flexible, progressive mind-set

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