Senior Director, Global Pharmacovigilance - United States
The Senior Director of Pharmacovigilance position provides leadership and management for the infrastructure of the Global Pharmacovigilance Department - Americas, as well as input into globalization of pharmacovigilance. Accountable for ensuring safety systems and procedures are in place to support a global pharmacovigilance system. Planned focus for this position is to be responsible for strategic and operational input and implementation of a global pharmacovigilance system with other pharmacovigilance heads in Asia and EMEA.
MAJOR DUTIES OF POSITION
- Supports oversight of the Santen global PV system to enable compliance with applicable regulatory PV requirements and guidance.
- Responsible for participating in creation of organizational strategy, goals, and objectives for the department as well as global pharmacovigilance group and ensures 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).
- Oversees appropriate performance of delegates engaged to conduct any PV operation on behalf of or for Santen in compliance with the applicable regulatory PV requirements and guidance as well as with Santen standards. Such delegates may be Santen employees or contractual partners such as consultants, service providers or development or other business partners.
- Maintain awareness of new and emerging safety concerns and related communications to the competent authorities in a time frame appropriate to the benefit-risk assessment in the applicable areas in cooperation with global PV processes.
- Provides input into responses to inquiries from regulatory authorities or health care professionals on safety issues
- Partners with other regional pharmacovigilance counterparts to ensure presence of coordinated global pharmacovigilance system
- Ensures development and updates concerning safety input to the core data sheet, the investigator’s brochure, label, RMP and any other safety document for a Santen product in which a product safety lead is identified as accountable in the PV unit.
- Pharmacovigilance Committee responsibilities including Secretariat of Global Product Safety Evaluation Committee, responsible for strategy input and globalization of pharmacovigilance group.
- Accountable for coaching and developing pharmacovigilance department by providing an environment that encourages ongoing personal and professional development.
- Accountable for assessment of performance of assigned personnel against departmental processes, standards and performance goals, and for ensuring successful completion of all training required for each role. Responsible for process and performance improvement plan as needed to achieve departmental standards.
- Accountable for oversight of PV activities related to licensing partners and CROs.
- Expected to further develop own potential succession candidateCollaborates with other departments to provide expertise and guidance to personnel regarding good pharmacovigilance practices.Interacts with other Santen Pharmacovigilance Units, Affiliates and Service Providers as required to address safety queries, share best practices, and discuss new safety regulations.
- Perform other duties as necessary as assigned by management
KNOWLEDGE AND SKILL REQUIREMENTS:
- MD, RN, BSN, Pharmacist, Physician Assistant or related degree.
- Minimum fifteen (15+) or more years Pharmacovigilance experience with at least five (5) years of department management experience.
- Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries in preparation of these reports preferred.
- Excellent understanding of clinical trial methodology, GCP and medical terminology.
- Attention to detail and quality focused.
- Strong organizational and project management skills.
- Strong negotiation and communication skills and the ability to operate effectively in an international environment.
- 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 through effective innovative leadership ability.
- Ability to mentor, and coach within IMS and cross functionally.
- Ability to lead global work groups.
- Ability to lead and deliver initiatives with positive examples by providing assistance, recognition and encouragement.