MedFocus Pharmacovigilance Director in Massachusetts

  • 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

  • Collaborate, negotiate and innovate to attain/maintain efficient processes for safety information reporting and tracking

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

ACCOUNTABILITIES:

  • 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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Registered Health Care Professional (Bachelor’s degree required)

  • 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 presentational skills

  • Flexible, progressive mind-set

PHYSICAL DEMANDS:

  • Routine demands of an office based environment.

TRAVEL REQUIREMENTS:

  • Some travel to global COMPANY sites may be required.

Please send resume to jobs@inventivhealth.com

Min Salary: $0.00

Max Salary: $0.00

State: MA