Director, Product Lead - Clinical Safety & Pharmacovigilance

4h4 hours ago

Otsuka Pharmaceutical Companies

Princeton, US · Full-time · $209,599 – $313,375

About this role

This Director provides oversight of the safety profile of assigned Otsuka products, including both drugs and devices, across post-market and clinical development programs. The role ensures patient and consumer safety through monitoring adverse events, conducting risk analysis, and adhering to GCP and regulatory guidelines.

Day-to-day responsibilities include medical analysis and decision-making for Company Core Safety Information, periodic safety update reports, signal detection activities, and risk management plans. The Director also collaborates with Early Development teams to embed safety considerations in protocol design, dose escalation strategies, and first-in-human risk assessments.

This role represents Clinical Safety and Pharmacovigilance at Labeling Committee and Executive Committee discussions, as well as interdepartmental meetings with licensing partners, contract research organizations, and clinical site investigators. The Director maintains thorough knowledge of internal and external interactions and the scope of work assigned to the department.

Opportunities include shaping robust safety strategies from first-in-human studies through proof-of-concept and supporting timely, high-quality safety deliverables for global submissions such as IND, NDA, and MAA. The Director also contributes to the creation and revision of SOPs and keeps abreast of industry standards for signal detection and risk communication.

Requirements

Medical analysis and decision-making skills for developing and maintaining Company Core Safety Information.
Experience with ad hoc aggregate safety reports, periodic safety update reports (PSURs), signal detection activities, and risk management plans (RMPs/REMS).
Proactive engagement in early-stage clinical trial design and safety monitoring.
Ability to serve as product/medical monitor to coordinate clinical study safety and spontaneous reporting.
Thorough understanding of internal and external interactions and scope of work assigned to the CS&PV department.
Experience preparing and reviewing safety summaries for inclusion in medical information write-ups, including analysis of similar events in alert reports.
Knowledge of industry standards and initiatives regarding signal detection, risk management, and risk communication.

Responsibilities

Maintain accurate and complete knowledge of assigned investigational and marketed products, including those in early development monitored by Otsuka, co-marketers, cosponsors, and affiliates.
Serve as primary on the development, implementation, and maintenance of the OPDC-CS&PV signal detection process, 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.
Manage continuous analysis of adverse events to identify signals and trends for assigned products, including early phase trials.
Perform review and approval of clinical trial medical coding and review protocols, case report forms, investigator brochures, package inserts, and NDA/PLA documents.
Provide strategic input and author/review safety sections for regulatory filings, including INDs, NDAs, MAAs, and other submissions.
Represent CS&PV at interdepartmental team meetings and contribute on safety topics at meetings with licensing partners, agents, contract research organizations, and clinical site investigators.
Keep CS&PV Senior Director and Management informed of any critical safety issues on monitored products.

Benefits

Opportunity to shape safety strategies from first-in-human studies through global regulatory submissions.
Collaboration with cross-functional teams including Early Development, Labeling Committee, and Executive Committee.
Involvement in cutting-edge signal detection and risk management initiatives.
Representation of CS&PV at meetings with licensing partners and regulatory agencies.