Otsuka America, Inc. · 1 day ago
Director, Product Lead, Clinical Safety & Pharmacovigilance (CSPV)
Princeton, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$210K/yr - $313K/yr
5+ years expOtsuka is a pharmaceutical company focused on providing oversight of the safety profile of its products. The Director of Clinical Safety and Pharmacovigilance will monitor safety data, conduct risk analysis, and ensure compliance with regulatory guidelines to protect patient safety and support product development.
Consumer GoodsDietary SupplementsPharmaceutical
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
Qualification
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 how/when to apply organizational policy or procedures to a variety of situations
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
MD degree with US medical license is required
Demonstrated experience (at least 5-7 years) as a Safety/PV professional in a pharmaceutical industry
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
Preferred
Experience with both development and product launch/post marketed products preferred
Direct experience in early development safety monitoring and strategy is highly desirable
Benefits
Comprehensive medical, dental, vision, prescription drug coverage
Company provided basic life
Accidental death & dismemberment
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
A generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Other company provided benefits
Company
Otsuka America, Inc.
For almost 100 years, Otsuka has been committed to creating innovative treatments that enhance and promote better health and overall well-being.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
T
Tatsuo Higuchi
CEO
L
Les Hine
Strategic Advisor
Recent News
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2025-04-29
2025-02-16
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