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Otsuka Pharmaceutical Companies (U.S.) · 5 hours ago

Director, Product Lead, Clinical Safety & Pharmacovigilance (CSPV)

Princeton, NJ

Full-time

Onsite

Lead/Staff, Director/Executive

$210K/yr - $313K/yr

5+ years exp

Otsuka Pharmaceutical Companies (U.S.) is seeking a Director of Clinical Safety and Pharmacovigilance (CSPV) to oversee the safety profile of assigned Otsuka products. The role involves monitoring safety data, conducting risk analysis, and ensuring compliance with regulatory guidelines to protect patient safety and manage legal implications.

Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

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

Clinical trainingFDA regulationsGlobal regulatory filingsEarly development safety strategySignal detectionRisk managementCommunication skillsLeadership skillsMicrosoft OfficeInterpersonal skillsOrganizational skillsCollaboration skills

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 Pharmaceutical Companies (U.S.)

Glassdoor4.1

There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.

Founded in 1989

Rockville, Maryland, USA

1001-5000 employees

https://www.otsuka-us.com

H1B Sponsorship

Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (8)

2024 (6)

2023 (11)

2022 (5)

2021 (9)

2020 (13)