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Pharmacovigilance Licensing Specialist

Your Title: Senior Pharmacovigilance Licensing Specialist

A Major Pharmaceutical Client of Real Staffing has a new role available!

This is a 12 month contract that can extend or convert full time.

The role is located On-site in Cambridge, MA.

Your Duties:

You will be responsible for supporting the management of the production, maintenance, revision and compliance of Pharmacovigilance Agreements (PVAs) with potential and active third parties across all therapeutic areas.

Your Responsibilities, broken down:

  • 20% of your time will be spent doing Review, revision, negotiation and document management for PV agreements.
  • 30% of your time will be spent to maintain processes, tools, and systems for PV Agreements
  • 10% of your time will go to the training of Global Pharmacovigilance personnel on new and existing PVAs, including key messaging pertaining to commitments.
  • 40% of your time will go to Development and management of compliance tracking processes and systems

Your Qualifications:

  • Bachelor's degree, or more advanced degree in relevant discipline
  • Minimum of 3 years' experience in the pharmaceutical industry or related field (eg, pharmacovigilance, clinical, regulatory, quality, or legal)

Your Key Skills, Abilities, and Competencies

  • Project management and meeting facilitation skills
  • Interpersonal, diplomatic, and collaboration skills
  • Oral and written communication skills
  • Excellent technical skills (eg, word processing, spreadsheets, charts/graphs, databases, and online research)
  • Strong working knowledge of pharmacovigilance regulations (GVP, ICH, GCP)
  • Ability to ensure appropriate documentation demonstrating compliance with regulations
  • General experience with creation and management of contracts
  • Proven ability to work in a complex, fast-paced matrix environment with both internal and external parties

Additional Skills:

  • Ability to negotiate with vendors, partners and key stakeholders to ensure compliance for our client and our client's partners.
  • Ability to understand different types of agreements and the safety information that may be related to each type of agreement.

Strong communications skills are essential, since you will work with the following departments and people:

  • Internal contacts include Global Drug Safety, Marketing, Regulatory Labeling, Regulatory Affairs, Medical Affairs, Quality, Local Country Personnel, Procurement and Legal.
  • External contacts include PV Business Partners, vendors and service providers.

Why work for this company?

  • Our client is located in a central and beautiful office location in Cambridge, Massachusetts. Our contractors with this client average a 21 month duration after extensions and 87% of our contractors have recommended this location to a friend!
  • This is a fantastic opportunity to break into Pharmaceuticals and utilize your legal or contracts knowledge to advance the future of drug treatments!

Sthree US is acting as an Employment Business in relation to this vacancy.