Associate Director - Pharmacovigilance

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