Associate Director - Pharmacovigilance

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