Drug Safety Associate

  • location: Cambridge, MA
  • type: Contract
  • salary: $44.40 - $52.23 per hour
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job description

Drug Safety Associate

Sr Pharmacovigilance Licensing Specialist

Job Summary

This position supports the management of the production, maintenance, revision and compliance of Pharmacovigilance Agreements (PVAs) with potential and active third parties across all therapeutic areas.

Job Responsibilities

  • 20% - Review, revision, negotiation and document management for PV agreements
  • 30% - Maintain processes, tools, and systems for PV Agreements
  • 10% - Training of Global Pharmacovigilance personnel on new and existing PVAs, including key messaging pertaining to commitments
  • 40% - Development and management of compliance tracking processes and systems
Education & 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
  • Excellent project management and meeting facilitation skills
  • Excellent interpersonal, diplomatic, and collaboration skills
  • Excellent 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
  • Complexity and Problem Solving
  • Excellent attention to detail, judgment, and problem solving skills
  • Ability to negotiate with vendors, partners and key stakeholders to ensure compliance for the client and the client's partner's.
  • Ability to understand different types of agreements and the safety information that may be related to each type of agreement.
  • 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.
  • Attendance and participation in meetings as required
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
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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