Job Description: The Manager of PV Operations will provide oversight of the PV operational and case management activities for safety reporting including the collection, processing, and reporting/submission of safety information for all Otsuka products (investigational and commercial) including the review and monitoring of various monitoring reports and other oversight activities. Supervise GPV local contract resources. Leverage knowledge of CFR, ICH and EU PV legislation, MedDRA and WHO-DD coding, to ensure high quality and compliance. Effectively manage, distribute and assign workload to colleagues and contract resources to ensure effective resource utilization. Effectively collaborate with multiple stakeholders internally, externally, and with the vendor(s) to ensure compliance and high-quality standards. The individual in this position must be able to manage multiple tasks simultaneously and prioritize competing requests or projects.
Other responsibilities include but are not limited to:
* Escalate issues to management as needed * Work with Director of PV with PV vendor management oversight activities including day-to-day oversight, review, and evaluation of the vendor performance and quality * Lead and provide safety operations support on assigned studies * Manage and ensure appropriate product coverage through safety colleague assignments. * Manage and improve ICSR activities and procedures. * Ensure compliance with procedures and reporting timelines. * Collaborate with PV Quality and Compliance and Safety Data Management to develop monitoring reports and procedures. * Responsible for the maintenance of Safety Associate and Specialist training and ensuring the training and mentoring of new Safety Associates and Specialists. * Leverage ICSR case assessment expertise and in collaboration with Product Medical Directors, ensure appropriate decision making around case assessments. * Collaborate with Safety Data Management to drive effective case workflows that are aligned and integrated with procedures. * Ensure appropriate clinical safety support for OPDC clinical projects, including those conducted in conjunction with affiliates, co-marketers, or Contract Research Organizations (CRO). * Provide direction and guidance to Safety Associates supporting clinical projects, including activities such as:
Reconciliation of adverse events
Preparation and submission of product-specific reports in accordance with departmental and company guidelines.
Communication of monthly adverse event reports, product safety issues, and any related problems and concerns to CS team members and management in a timely manner.
Clinical project start-up activities such as presentation for Investigators meeting and interdepartmental training.
Interactions with Contract Resource Organizations.
* Review documents related to safety case processing and reporting such as Safety Management Plan, Safety Reporting Forms and completion guidelines, reconciliation plan, data handling conventions * Monitor and ensure timely submission of ICSR reports to Competent Authorities * Drive initiatives to improve quality of ICSRs and compliance. * Perform other tasks as assigned by the management of global PV * Contribute to development and maintenance of Safety Data Exchange Agreements (SDEAs) and PV agreements with partners, vendors, and other third parties * Monitor and oversee interactions with Alliance Partners in alignment with pharmacovigilance agreements * Interact with Inspectors during Competent Authority Inspections (PV & GCP) and ensure timely and quality responses to inspection requests. * Contribute to safety requests from Regulatory Authorities * Participate in the development and maintenance of PV System policies, SOP forms, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices * Collaborate with Medical Affairs, Commercial, or Marketing to develop processes, forms, and/or training to support Patient Support Programs, Market Research, and Investigator Initiated Studies
Knowledge, Skills, Competencies, Education, and Experience Required:
Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.)
Minimum of 5-7 years of direct pharmacovigilance experience
Experience with safety databases (ARGUS, ARISg, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems.
Knowledge of GCPs, ICH guidelines and FDA, EMA, and other international regulations and guidelines
Working knowledge of MedDRA and WHO Drug dictionaries
Experience with onboarding, oversight and management of safety vendors
Strong interpersonal and communication skills; proactive approach.
Able to work both independently and in a team environment
Detail-oriented, with good organizational, prioritization, and time management proficiencies.
Must be able to work on multiple projects simultaneously
Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
Proficient in standard computer software (Word, Excel and Power point presentations)
Previous experience and formal training with safety database programs including configuration and validation activities is desired
Travel (approximately 30%)
Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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