- 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).
- Provides routine oversight of CMT-related activities for all products in the Genentech/ Roche portfolio under the direction of the CMT Head.
- Demonstrates understanding of appropriate labeling documents of Genentech/ Roche molecules and products.
- Accountable for the design and implementation of strategic, operational and personnel plans for assigned CMT-related activities. This includes, but is not limited to, the intake and submission of spontaneous reports as well as safety support and direction for US Medical Affairs sponsored and supported interventional and non-interventional studies and programs.
- Participates in the creation of the organizational strategy, goals, and objectives for the CMT, and assists in the implementation of the business plans to support both local and global safety strategies (e.g., rollout of new safety initiatives, implementation of new Health Authority safety requirements).
- Establishes collaborations with other departments to provide guidance to personnel for interdepartmental and cross-functional team activities, including process improvement standards and metrics.
- Participates in interactions with Global Drug Safety and other Affiliates to address safety queries, share best practices, and discuss new safety regulations.
- Responsible for the oversight of ICSR activities and applicable safety commitments for all licensing partners
- In collaboration with USDS Leadership Team will 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 identification of talent to be developed into potential succession candidates.
- Through coordination with the USDS 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.
- Exhibits sound decision-making skills with the ability to evaluate and analyze strategies to achieve results.
- Displays a high level of commitment.
- Generates enthusiasm and drive for commitment to excellence.
- Health Care Professional (HCP) or individuals with Master’s degree with relevant pharmaceutical industry experience in Pharmacovigilance.
- Minimum of 6 years recent experience in the pharmaceutical industry. Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations. Knowledge of EMEA regulations preferred.
- Minimum of 2 years experience in supervisory role preferably in a comparable drug safety organization.
- Computer proficiency and data entry experience (Preferred).
Job ID: 201805-107746