Director, Product Lead, Clinical Safety & Pharmacovigilance; CSPV

Position: Director, Product Lead, Clinical Safety & Pharmacovigilance (CSPV)
* Maintains accurate and complete knowledge of assigned investigational and marketed products, including those in early development being monitored by Otsuka, co-marketers, cosponsors, and/ or affiliates.
* Serves as primary on the development, implementation, and maintenance of OPDC-CS&PV signal detection process. Works in conjunction with related departments to develop and maintain a signal detection plan for use in all product life cycles, with emphasis on early-stage risk identification.
* Collaborate with Early Development teams to ensure safety considerations are embedded in protocol design, dose escalation strategies, and first-in-human risk assessments.
* Keeps abreast of industry standards and initiatives regarding signal detection, risk management, and risk communication.
* Represents CS&PV at Labeling Committee/ Executive Committee discussions on new information impacting product profile.
* Manages the continuous analysis of adverse events to identify signals and trends for assigned products, including early phase trials.
* Performs review and approval of the clinical trial medical coding.
* Participate in the creation and revisioning of SOPs for Department and OPDC.
* Provide strategic input on safety issues during early development portfolio reviews and governance meetings.
* Serves as product/ medical monitor to coordinate clinical study safety and spontaneous reporting of assigned Otsuka products.
* Maintains a thorough understanding of internal and external interactions, and scope of work assigned to CS&PV department.
* Meets routinely with product-specific CS&PV team members to review and communicate product safety issues.
* Reviews each product (e.g., IND/NDA Periodic, CSR, Summary Analysis, etc.) and accompanying data for completeness, consistency, accuracy and clarity.
* Prepares/review safety summaries for inclusion in medical information write-ups, including analysis of similar events in alert reports.
* Keeps CS&PV Sr. Director and Management informed of any critical safety issues on monitored products.
* Represents CS&PV at interdepartmental team meetings.
* Represents CS&PV and contributes on safety topics at meetings conducted with licensing partners, agents, contract research organizations, and clinical site investigators.
* Provides review of protocols, case report forms, investigator brochures, package inserts, and NDA/PLA documents, including patient narratives.
* Provide strategic input and author/review safety sections for regulatory filings, including INDs, NDAs, MAAs, and other global submissions.
* Serves as liaison, in conjunction with Regulatory Department, with regulatory agencies on product safety issues.
* Serves as mentor and resource for CS&PV Associates, Assistants, Scientists and Safety physicians.
* Participates in providing training to CS&PV team members and other Otsuka staff as appropriate, on the epidemiological and regulatory aspects of programs.
* Provides and establishes direct liaison with the CS&PV team members, OFRI, and OPC counterparts, and other functional areas.
* Utilizes technical/medical knowledge to assist CS&PV team members in the assessment of adverse event reports.
• Keeps abreast of current developments in the field and maintain knowledge base by attending seminars, professional association meetings, and maintaining industry and professional network.
* Serves as backup for the Senior Director where required.
* Requires a strong medical background evidenced by clinical training
* Solid knowledge of FDA and global PV regulations.
* Knowledge of clinical trials, good clinical practices, and ICH guidelines.
* Expertise in early development safety strategy, including first-in-human risk assessment.
* Experience in preparing and reviewing safety content for global regulatory filings (IND/NDA/MAA).
* Experience of working in a global setting
* Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.
* Strong communication and leadership skills.
* Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word,
* Excel, PowerPoint, and Outlook).
* Knows…