Associate Director, Global Pharmacovigilance

Job Description

• Provide direct supervision and mentor staff within the ICSR Processes and Systems team
• Develop, the strategy, standards, and conventions for Case Processing
• Support the Process Owners Network (PON) by ensuring accurate and compliant R&D controlled procedures are in place for following Sub-Process Owner (SPO) areas: Case Processing Oversight and Process Safety Information
• Develop, the strategy and database requirements for the Global Safety Database including advising on prioritization of change requests/upgrades
• Represent GCM in the governance of the Global Safety Database vendor including being a participating member in the Industry Standard Practices (ISP) consortium led by the GSD vendor
• Collaborate on and contribute to the GCM system design/requirements, validation assessment and prioritization with R&D IT and R&D QA as needed for systems such as, but no limited to, AESI related tools, oversight tools and imaging tools
• Participate in strategic planning and execution of key safety system projects (e.g., GSD transfer as a result of asset acquisitions/divestitures, safety database upgrades, new technology launches, system vendor transitions, etc.)
• Ensure standards and processes are compliant with global regulatory and Biogen requirements
• Deliver training for the GSD to PV team members and vendors, as needed
• Director of the MCPHS University Post-Doctoral PharmD Pharmacovigilance Fellowship
• Provide input as a PV Subject Matter Expect and participate in Audits and Inspections as a SME

Qualifications

• Subject Matter Expert in Pharmacovigilance and drug development; including knowledge of applicable clinical trial safety regulations (GCP, GVP) and post-marketing safety regulations. Includes knowledge of case processing, clinical trial study management, and safety database concepts. Demonstrated ability to mentor others and lead teams in decision making impacted by PV and drug development requirements.
• Demonstrated effective leadership in a fast-paced cross functional team environment with individuals across all levels within an organization including Safety, Clinical Operations, Medical Affairs, Regulatory, R&D IT, R&D Quality and Biometrics, as well as with external key stakeholders and corporate partners.
• Effective managerial skills, being a self-starter, ability to work independently, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize
• Must demonstrate initiative to identify and communicate issues within department and across departments
• Ability for individual decision-making required
• Excellent communication skills (written and verbal)
• Ability to interact collaboratively in a team environment

• Minimum of Bachelor's level degree in nursing, pharmacy, or other health related profession. Alternately a Bachelor's level degree in life sciences.
• Minimum 4+ Years in Drug Safety Department in the pharmaceutical/ biopharmaceutical industry.
• Minimum 2+ years managing direct reports
• 3+ years in a Clinical Setting (preferred but not required).

Additional Information

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