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.