Director, Product Lead - Clinical Safety & Pharmacovigilance

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.

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

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $209,599.00 - Maximum $313,375.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Company 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, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings;https://www.otsuka-us.com/careers-join-otsuka.

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