Full-Time

Associate Director

Pharmacovigilance

Integrated Resources

Integrated Resources

501-1,000 employees

No salary listed

Cambridge, MA, USA

In Person

Category
Biology & Biotech (2)
,
Requirements
  • Bachelor’s degree required; Post-graduate degree or equivalent (Master’s Degree/MBA) preferred
  • Minimum 8 years’ experience in pharmaceutical/biotech industry with minimum 4 years’ experience in Pharmacovigilance, clinical research, or alliance management role
  • Experience in developing PV safety agreements, safety team charters, service level experience
  • Experience in and knowledge of due diligence for company acquisitions and/or licensing partnerships
  • Product development including clinical safety experience
  • Ability to interact effectively with staff of multiple disciplines both within and outside the company nationally and internationally
  • Demonstrated ability and experience leading high performing teams internally and cross functionally in a global highly matrixed and collaborative environment
  • Ability to proactively identify and anticipate risks associated with non-adherence to the regulations
  • Strong understanding and knowledge of business areas both internally and touch points externally
  • Excellent time management skills
  • Self-starter and strategic thinker
  • Able to lead teleconferences and meetings
  • Project management training and experience
  • Proven ability to create and implement operational efficiencies
  • Excellent oral and written communication skills
  • Strong relationship management skills
  • Expertise in clinical research and product safety activities in the pharmaceutical industry
  • Ability to handle confidential information appropriately
  • All information will be kept confidential according to EEO guidelines
Responsibilities
  • Implement process improvement and increased efficiencies for global pharmacovigilance
  • Contribute to pharmacovigilance due diligence/business development activities
  • SDEAs and PVAs
  • Implement a scalable process for managing and tracking safety exchange agreements/documents (SDEAs, PVAs, Charters, SLAs, etc.)
  • Review and provide input on SDEAs, PVAs, Charters, and associated Safety Agreement documents
  • Collaborate with the PV Compliance group to address and resolve compliance issues associated with SDEAs/PVAs
  • Partner with key stakeholders to contribute to the development and maintenance of a global SDEA/PVA template
  • Participate in meetings related to partner alliance and cross-program global operations as required.
  • Identify and work to resolve issues in PV alliances/partnerships.
  • Escalate issues in PV alliances to senior management as appropriate.
  • Provide strategic contributions to PV due diligence/business development activities
  • Product/company acquisition or licensing
  • Due diligence activities for global PV
  • Due diligence process documents
  • Escalate issues/problems to senior management as needed
  • Any other tasks assigned by manager to assist in departmental activities

Company Size

501-1,000

Company Stage

N/A

Total Funding

N/A

Headquarters

Edison, New Jersey

Founded

1996

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Simplify's Take

What believers are saying

  • Certification boosts appeal to quality-focused healthcare organizations.
  • Reskilling programs cut time-to-hire amid workforce shortages.
  • Positions IRI among 15,000 Joint Commission-accredited elite firms.

What critics are saying

  • Certification lapses in 12-18 months from failed onsite review.
  • Patient complaints trigger decertification and client losses in 6-12 months.
  • AMN Healthcare captures IRI's mid-sized clients in 12-24 months.

What makes Integrated Resources unique

  • Joint Commission Gold Seal certifies IRI's staffing compliance since 2009.
  • AI tool Nova hybridizes with reskilling to close healthcare skills gaps.
  • Focuses on diversity hiring and performance monitoring for elite placements.

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Benefits

Wellness Program

Mental Health Support

Flexible Work Hours

Phone/Internet Stipend

Home Office Stipend

Conference Attendance Budget

Company News

Integrated Resources, Inc.
Jan 3rd, 2024
Integrated Resources Inc. Awarded Health Care Staffing Services Certification from The Joint Commission

Edison, New Jersey - Integrated Resources Inc. has earned The Joint Commission's Gold Seal of Approval(R) for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.

Integrated Resources, Inc.
Feb 1st, 2023
Integrated Resources Inc. Awarded Health Care Staffing Services Certification from The Joint Commission

Integrated Resources Inc. has earned The Joint Commission’s Gold Seal of Approval ® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.