PRIMARY PURPOSE OF POSITION:
This position is seen as value-added for the organization as Santen matures in its effort towards globalization. One primary purpose of this role is to establish and maintain relationships within a high performing team to help ensure successful project completion as assigned. The PV Specialist II works closely with internal stakeholders and external partners for the smooth execution of projects. In this capacity, the successful candidate will be responsible for support in managing local (U.S.) and global Pharmacovigilance projects including those overseen by the Product Safety Lead position. This can include designing the project framework, defining the scope of a project, and support in creating robust agendas for local and global meetings. The PV Specialist II will also have the opportunity to contribute to the content of the projects managed.
The PV Specialist II will provide Pharmacovigilance support. This will include a role as a global Product Safety Lead for an assigned product. Other roles will include membership or leadership role on global work streams and/or task forces. The purpose of this role is to support establishment and maintenance of risk/benefit profiles for Santen molecules. This position supports Pharmacovigilance which operates in a highly regulated global environment with the need to adhere to tight time lines while maintaining a high standard of accuracy in compliance with standard operating procedures and global and local regulatory requirements.
MAJOR DUTIES OF POSITION:
- Serves as liaison and bridge for Pharmacovigilance matters to support alignment with Santen’s corporate office in Osaka, Japan and globally.
- Advocates for a project management framework, including global projects. Develops tools, templates and methodologies which can be leveraged by the Pharmacovigilance group.
- Manages scope, cost, resources and stakeholders’ expectations to deliver projects within time and budget. Communicates project objectives and overviews for both local and global projects, role and responsibilities, and success criteria as assigned. Operates in a proactive, supportive fashion.
- For local and global projects/work streams and task forces, responsible for helping with the following: identifying stakeholders, defining communication plan, identifying metrics, identifying risk and subsequent mitigation strategies as well as contribute to safety content.
- Promotes collaborative work environment. Leverages organizational culture and project historical data for successful delivery of deliverables. Manages change, as appropriate.
- Identifies opportunities for improvements and makes constructive suggestions for change.
- As a team member or Product Safety Lead, may contribute to content and deliverables as appropriate.
- Day to day operational support includes: triage on all case types; data entry into the global Drug Safety Database; thoughtful, concise narrative writing; labeling and case assessment; initiation of critical follow-up requests; consults / collaborates with internal and external colleagues and departments. Performs Quality Assurance checks of ICSRs. Identifies potential product complaints and processes accordingly.
- Manages vendors and external partners globally. Responsible for training program and documentation for annual training vendor “trainers” on reporting of safety information to Santen. Drafting, coordinating and sign off on a Safety Management Plan and support of its required activities.
- Identifies opportunities for improvements, makes constructive suggestions for change and able to influence diverse groups of people.
- Participate in development and review of content for SOPs and safety presentations.
- Involved in clinical research activities, safety training of investigators and CRAs. Perform reconciliation between Global Drug Safety Database and Clinical Database.
- Ability to provide secondary support for database and other PV systems as requested including support with pharmacovigilance database validation, implementation, documentation, training, strategy and ongoing global use.
- Contributes to global aggregate reporting; accountable for signal management for assigned products; presents at Global Product Safety Evaluation Committee.
- Represents PV on product governance teams, including protocol execution teams.
- Performs other duties as assigned by management.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Fluency in English with Japanese language ability preferred.
- MD, PharmD., RN, BSN, Nurse Practitioner, Pharmacist or related degreerequired
- Minimum 5 years of relevant experience in Project Management in the Pharmaceutical Industry with expertise in managing cross-functional teams and projects required.
- Minimum 3years of Pharmacovigilance experiencerequired.
- Proven understanding of physiology, pharmacology, clinical study objectives, and the drug development process.
- Proficiency with case data entry using safety data base systems such as ARGUS
- Experience in safety document or medical writing including experience coding with MedDRA dictionaries in preparation of these reports required
- Excellent understanding of clinical trial methodology, GCP and medical terminology
- Knowledge of FDA and international ADE reporting regulations per guidelines and ability to meet timelines as necessary for regulatory reporting purposes.
- Attention to detail and quality focused with analytical skills and ability to think strategically
- Strong organization and communication skills, and the ability to operate effectively in an international environment with different business cultures.
- Understands business background and cross-functional business processes.
- Demonstrated success in leading teams and projects
- Strong technical and problem solving skills acumen.
- Strong process orientation and a solid understanding of project management techniques, methodologies and best practices
- Excellent verbal, written and presentation skills. Good presentation skills—the ability to convey complex information to diverse audiences.
- Ability to influence team members within matrix organization structure.
- Ability to work independently, under pressure, demonstrating initiative and flexibility. However, timely escalation with necessary documentation is expected.
- Previous experience working with diverse cultures, in particular with Japanese businesses, is a plus
- Proficiency with Microsoft Office Suite of software. Experience in managing business applications and business processes preferred, including Project Management software and Visio.
- Ability to manage multiple priorities without losing focus.
- Ability to demonstrate passion for project management and a strong aptitude for interpreting business strategy.
- Desire to learn and implement new project/program management philosophies and strategies
- Proven ability to influence change and build consensus towards effective partnerships in a matrix environment.
- Creative problem solving, mature approach and dedication to continuous improvement.
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 requirements listed are representative of the knowledge, skill, and/or ability required. The individual must be able to:
- Spend considerable time spent at the computer
- Must be able to stand, kneel and stoop for filing
- Must be able to use the telephone and speak with external individuals
- Able to lift up to 25lbs
- Must able to travel domestically and internationally without restriction, up to 25%