Demonstrates high level proficiency and expertise of drug safety concepts to include monitoring, tracking, and completion in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) related standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs). Able to effectively demonstrate strong leadership across all Case Management Manager related activities and extensive breath of knowledge of key stakeholders external to USDS.
Accountable and responsible for reconciliation activities related to ICSR processing
Collaborates with other key stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards and metrics
Responsible for implementing PV related activities within the scope of PV operations as outlined in relevant agreements with license partners and/or other parties [as required]
Maintains strong relationships with Global Safety and other Affiliates to share best practices
Responsible for the oversight of ICSR activities as they pertain to PV operations
Demonstrates expertise in study management and Market Research and Patient Program [MAP] activities
Accountable for maintaining oversight over Source data quality check [SDQC] activities and ensure tracking and timely completion
Will collaborate with USDS Leadership Team to drive the organizational strategy, goals, and objectives for the department, and will determine the processes needed to support both local and global safety strategies
Accountable for coaching and developing direct reports by providing an environment that encourages ongoing personal and professional development
Responsible for the performance of assigned personnel against departmental processes, standards and performance goals, and for ensuring successful completion of all training required for the role
Responsible for the identification of talent to be developed into potential succession candidates.
Through coordination with the USMA Compliance and Training team to ensure appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits
Act as Subject Matter Expert (SME) for safety related activities per Genentech/Roche SOPs
Competencies Identified for Success:
Works effectively, independently and collaboratively
Strong organizational skills, detail oriented and adapts in a dynamic, fast paced environment
Demonstrates ownership, initiative and accountability
Exemplifies strong, dynamic leadership and mentoring skills.
Ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting
Excellent communication skills, both written and verbal, with credibility and confidence
Sound strategic evaluation, analysis, and decision making skills as demonstrated in effective strategy formulation, tactics and action plans to achieve results
Displays a high level of commitment
Generates enthusiasm and drive for commitment to excellence
Education, Experience, and Other Requirements:
Bachelor’s degree in a health care field with relevant pharmaceutical industry experience in drug safety. Candidates with advanced scientific degrees and extensive drug safety experience is highly desired.
Minimum of 10 years recent experience in the pharmaceutical industry with 12-15 or more years experience highly desired.
Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
Minimum of 5 years experience in management capacity preferably in a comparable drug safety organization.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
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