PRIMARY PURPOSE OF POSITION:
This position is responsible for department leadership and management of the operational group and infrastructure of the Global Pharmacovigilance (PV) Department, United States. Responsible for collaborating with colleagues across functions and regions for continuous improvement of PV and related processes, systematic set up and maintenance of training plans, documentation and review as well as management of local SOPs and assigned global SOPs, inspection readiness and other functions and processes critical to pharmacovigilance. Planned focus for this position is leadership towards and full accountability for all activities within the scope of Global Pharmacovigilance, United States supporting global products. These responsibilities are performed under the direction of the Senior Director, Global Pharmacovigilance.
MAJOR DUTIES OF POSITION:
• Accountable for the design and implementation of on-boarding procedures, operational and personnel plans for assigned PV personnel as well as other identified GCD&MA activities related to PV.
• Oversees pharmacovigilance management of EU/US (global) safety database.
• Oversees local and global SOPs towards harmonizing the PV departments within Santen including participating in development and review of content for conventions, SOPs and Working Documents.
• Stays current on relevant regulations and industry standards, including participation in benchmarking activities.
• 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 process and performance improvement plan as needed to achieve departmental standards.
• Supports and manages Safety training of internal and external personnel which includes, but is not limited to Investigator Meeting Drug Safety presentations, training of Santen staff and vendors on how to report safety information.
• Expected to further develop own potential succession candidate.
• Accountable for the Individual Case Safety Report process from intake through submission for all data collection schemes which may be local (FDA) or global in scope. Interact with the other Santen Affiliates as required to address safety queries, share best practices, and discuss new safety regulations. Interfaces with the clinical team for safety matters including follow-up on events of interest and input into site queries regarding adverse events.
• Supports oversight of PV activities related to licensing partners and service providers.
• Accountable for production of safety sections within regulatory documents that may include Investigator Brochures, Periodic Benefit Risk Evaluation Reports, and other aggregate reports.
• Accountable for licensing activities, regulatory authority inspections audits and for project product recall activities.
• Responsible for coordination of inspection readiness and creates, supports, and/or participates in the Corrective and Preventative Action (CAPA) planning in response to findings of non-compliance.
• Participates in review of clinical study protocols and reports and other regulatory documents as requested. Involved in the clinical research activities, representing PV Operations on clinical study teams. Interfaces with the clinical team for safety matters including follow-up on events of interest and input into site queries regarding adverse events.
• Assists in the maintenance and support of RMP(s) including the coordination with other line functions for associated activities such as updates, management of large datasets for analysis purposes and the ongoing tracking of commitments and effectiveness measures.
• Responsible for participating in creation of the organizational strategy, goals, and objectives for the department, and assists in the implementation of the business plans to support both local and global safety strategies (i.e., rollout of new safety initiatives, implementation of new Health Authority safety requirements).
• Collaborates with other departments (e.g., training) to provide PV expertise and guidance to personnel for interdepartmental and cross-functional team activities, including process improvement standards and metrics.
• Participates in the Request for Proposal (RFP) process and evaluates proposals based on global regulations. Subsequently manages and supports service providers throughout the contract.
• May also be assigned projects and programs to lead and facilitate as needed. May also be assigned the management of short-term business projects as well as global work streams and task forces.
• Accountable to management and external departments, as necessary.
KNOWLEDGE AND SKILL REQUIREMENTS:
• MD, RN, BSN, Nurse Practitioner, Pharmacist, Physician Assistant or related degree.
• Minimum 10 years of experience in a pharmaceutical company or clinical environment.
• Minimum 8 years Pharmacovigilance experience including knowledge of EU GVP and FDA regulations.
• Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports required.
• Experience in clinical trial set up, line management, PVA negotiations, and vendor management.
• Excellent understanding of clinical trial methodology, GCP and medical terminology.
• Attention to detail and quality focused.
• Strong organizational and project management skills.
• Strong communication skills, and the ability to effectively build relationships in an international environment where diverse cultures are represented.
• Excellent understanding of physiology, pharmacology, clinical study objectives, and the drug development process.
• Strong technical and problem solving skills.
• Good presentation skills.
• Fluency in English, with knowledge of other languages desirable.
• Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases applications.
• Ability to work independently, under pressure, demonstrating initiative and flexibility.
• Ability to function and communicate cross-functionally and cross-culturally.
• Ability to communicate and function with global work groups.
This section requires quantitative data that will help provide some measure of the size or scope of the position. Data should be on an annual basis.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The individual must be able to:..
• The individual must be able to stand, kneel and stoop for filing, use the computer, and use the telephone to speak with internal and external individuals.
• Considerable time spent at computer.
• Must be able to stand, kneel and stoop for filing.
• Must be able to use the telephone and speak with external individuals.
• Must be able and willing to travel domestically and globally, as needed; and at times, on short notice, up to 15%
WORK ENVIRONMENT and ENVIRONMENTAL CONDITIONS:
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.