Associate Director - Pharmacovigilance

  • Contract

Job Description

Associate Director of PV Business Development oversees global strategic initiatives and operational aspects of business development. Primary responsibilities include but are not limited to:

• Implement process improvement and increased efficiencies for global PV

• Contribute to PV due diligence/business development activities

ACCOUNTABILITIES:

(Describe the primary duties and responsibilities of the job. Approximately 5 – 10 bulleted task statements should be identified).

  • 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

General

  • Escalate issues/problems to senior management as needed
  • Any other tasks assigned by manager to assist in departmental activities

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor’s required. Post-graduate degree or equivalent (Master’s Degree/MBA) preferred
  • Experience in, but not limited to, 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 both 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 the business areas both internally within the organization 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

ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY):

  • Minimum 8 years’ experience in pharmaceutical/biotech industry with minimum 4 years’ experience in Pharmacovigilance, clinical research, or alliance management role

Additional Information

All your information will be kept confidential according to EEO guidelines.