Job Description

The Director, Clinical Safety and Pharmacovigilance (CSPV), provides oversight of the safety profile of assigned Otsuka products (both drugs and devices, post market products and clinical development programs) through monitoring safety data, conducting risk analysis, and monitoring adverse events according to GCP and regulatory guidelines, in order to protect the safety of the patients and consumers and the company from legal implications. In addition to core PV responsibilities, the Director will have special focus on Early Development programs and regulatory filing experience, ensuring robust safety strategies are integrated from first-in-human studies through proof-of-concept and supporting timely, high-quality safety deliverables for global submissions (IND, NDA, MAA). Key activities include medical analysis and decision making for the development and maintenance of the Company Core Safety Information, ad hoc aggregate safety reports, periodic safety update reports (PSURs), signal detection activities, risk management plan (RMPs/REMS) and individual case safety reports, with proactive engagement in early-stage clinical trial design and safety monitoring.

Key Job Responsibilities

• 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.

Knowledge, Skills, Competencies, Education, and Experience

Required:

Knowledge

• 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

Skills

• 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 how/when to apply organizational policy or procedures to a variety of situations.

Competencies

• Self-starter with proven ability to thrive in a fast-paced team environment handling multiple simultaneous high priority tasks
• Strong leadership, collaboration and interpersonal skills
• Ability to adapt to a dynamic work environment and drive early development safety initiatives

Education and Related Experience:

• MD degree with US medical license is required
• Demonstrated experience (at least 5-7 years) as a Safety/PV professional in a pharmaceutical industry
• Experience with both development and product launch/post marketed products preferred.
• Direct experience in early development safety monitoring and strategy is highly desirable.
• Ability to act as in-house authority/leader in Safety and Pharmacovigilance; and be fully accountable for Safety of assigned products.
• Experience interacting with global regulatory authorities

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