Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company. We are in a unique position of having the financial backing and the research capabilities of a well-established leading Japanese pharmaceutical company, matched with the entrepreneurial spirit of a start-up company.
Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain, women's health and anti-infectives. Together with our Japanese corporate parent, Shionogi has been providing innovative medicines essential to people's health for over 130 years.
Operations Leader in PSPV, leads the core PV operational functions including Case Management, Safety Systems, Alliance and Vendor Management, and Quality Management. The Pharmacovigilance
Operations Leader is responsible for management and oversight of PV operations and compliance with internal SOPs and applicable global/local regulations and guidelines. Will manage PVO's staff and daily activities relating to adverse event case processing and regulatory reporting for marketed and investigational products, Aggregate Reporting, and collaborate with colleagues in Clinical Operations, Regulatory Affairs, Data Management, Commercial, etc., as well as with external contacts, such as licensing partners, Contract Research Organizations, etc.
Prepare safety objectives and evaluates and manages performance of the PV team. Manage resources with respect to workload. Monitor monthly metrics and add workflow improvements to ensure quality and timeliness. Review quality and compliance of PV operations.
Ensure that the performance of direct reports is proactively managed and that they are coached, trained and developed to maximize their contributions. Enhance scientific and clinical experience of staff through continuous training and coaching. Responsible for attracting, retaining and developing talent within PVO.
Accountable for the delivery of high quality, timely and standardized safety deliverables, and provides content guidance and functional approval, as needed, for all safety documentation.
Adverse Event Case Processing includes ensuring that Individual Case Safety Reports (ICSR) from all sources (clinical trials, post-marketing, including solicited and literature) have timely and quality collection, processing, follow-up, analysis, and regulatory reporting to health authorizes (such as US FDA, EU, etc.) according to regulatory requirements, ICH, company SOPs and procedures.
Monitor and support the availability and use of the current reference safety documents for ICSR processing, aggregate safety reporting and safety data analyses.
Ensure timely submission to regulatory authorities and license partners.
Ensure appropriate and consistent MedDRA coding in compliance with company standards.
Oversee and contribute to the preparation & submission of aggregate reports to regulatory agencies in accordance with applicable regulations and internal Standard Operating Producers including Periodic Adverse Drug Experience Report, Periodic Safety Update Reports (PSURs)/Periodic Benefit- Risk Evaluation Report (PBRER), Development Safety Update Report, etc.
Provide safety data for signal detection, safety management team meetings and response to health authorizes.
Liaise with clinical study teams and/or medical monitor to oversee safety monitoring of clinical trials. Review SAE Management Plan, study protocols, statistical analysis plans, and other clinical study-related documents, as well as standard design of tables, figures and listing for safety data.
Participate in risk management and safety signal detection activities as needed. Contribute to safety contents for RMP and REMS as needed. Assist in development or update of strategy and content for regional RMP.
Recommend process improvements and modifications to the drug safety database, SOPs & working practices in support of continuous improvement. Preparation of new SOPs or modification of existing documentation in compliance with applicable regulations and local/ global SOPs.
Provide oversight for literature review process for local and assigned global products to identify ICSRs, signals, safety issues, aggregate report references, in compliance with regulations and Shionogi local/global SOPs.
Actively participates in regulatory inspections and internal audits and in collaboration with QA and Regulatory Affairs ensures appropriate and timely responses to findings Coordinates PV corrective action/preventive action (CAPA) plans, ensure appropriate root-cause analysis and documentation. Recommends process development or improvement as needed Enhances PV metrics capabilities.
Evaluates trend analyses as related to the ongoing assessment of PV quality, consistency, reporting compliance and operational effectiveness.
Review license partner agreements with regard to Safety and Pharmacovigilance activities. Coordinates and monitors the implementation of PV agreements and safety management plans with all license partners and vendors and continuously monitor performance and compliance.
Other Duties as needed.
Minimal (10-15%) travel could include domestic and international.
Minimum of 10 years of experience in Drug Safety/Pharmacovigilance.
Excellent written and verbal communication skills, organizational skills and attention to detail.
Demonstrated computer experience with validated global safety databases
Ability to effectively prioritize, multi-task and meet established deadlines.
Supervisory experience with the ability to effectively manage people and projects is essential.
Demonstrated computer experience with MS Word, Excel, Access and Outlook.
Must live a commutable distance from our Corporate Headquarters in Florham Park, NJ.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.