Director, Global Medical Review Lead (Remote) US or UK
Key Job Responsibilities
- Represents GPV Medical Safety department from a medical review standpoint as the key stakeholder in internal, external and health authority inspections, to ensure and sustain inspection readiness.
- Contributes to the development, creation, revisioning and authoring of medical review Standard Operating Procedures, Work Practices, Job Aids and other guidance documents relevant to medical review.
- Oversees medical review of Individual Case Safety Reports (ICSRs) as the global medical review lead to ensure quality and accuracy of ICSRs by implementing and overseeing key performance metrics.
- Chairs periodic global medical review meetings with the attendance of in-house, subsidiary, partner, and vendor medical reviewers.
- Provides oversight of the safety profile of Otsuka products (both drugs and devices) through monitoring safety data, conducting risk analysis, and monitoring adverse events according to GCP and regulatory guidelines, to protect the safety of the patients and consumers and the company from legal implications.
- Serves as back-up on the development, implementation, and maintenance of GPV signal detection process.
- Works in conjunction with related departments to develop and maintain a signal detection plan for use in all product life cycles. - Represents GPV at Labeling Committee/ Executive Committee discussions on new information impacting product profile.
- Keeps abreast of industry standards and initiatives regarding signal detection, risk management, and risk communication.
- Manages the continuous analysis of adverse events to identify safety signals and trends for assigned products.
- Performs review and approval of the clinical trial medical coding.
- Serves as back-up product/ medical monitor to coordinate clinical study safety and spontaneous reporting of assigned Otsuka products.
- Maintains accurate and complete knowledge of assigned investigational and marketed products being monitored by Otsuka, co-marketers, co-sponsors, and/ or affiliates.
- Maintains a thorough understanding of internal and external interactions, and scope of work assigned to GPV Medical Safety and PV Operations departments.
- Meets routinely with product specific GPV team members to review 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.
- Discusses safety issues with personnel in therapeutic specialty groups at meetings with vendors, licensing partners, agents, contract research organizations, and clinical site investigators.
- Serves as liaison, in conjunction with GPV Medical Safety Product Leaders, with regulatory agencies on product safety issues.
Knowledge, Skills, Competencies, Education, and Experience
- Strong knowledge of global regulatory guidelines pertaining to pharmacovigilance
- Strong knowledge of MedDRA and any safety databases
- 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.
- Oncology, Neurology or Cardiorenal experience is a plus.
- Experience working in a global and cross-functional pharma 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 Microsoft applications (Word, Excel, PowerPoint, Outlook, SharePoint, and Teams).
- Knows how/when to apply organizational policy or procedures to a variety of situations.
Education and Related Experience
- M.D. from an accredited medical school with at least 5 to 8 years of Safety Surveillance experience in pharmaceutical industry
- Experience with both development and product launch/post marketed products.
- Acted as in-house authority/leader in Safety and Pharmacovigilance, and accountable for Safety of assigned products.
- Experience interacting with global regulatory authorities such as EMA, MHRA, PMDA, Health Canada.
- Prior supervisory experience
Physical Demands and Work Environment
Travel (up to 15%)
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.
Annual Salary :Minimum $195,522.00 - Maximum $292,330.00, plus annual incentive: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, 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.
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
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