Daiichi Sankyo, Inc Hiring for Director, Aggregate Safety Reporting, Clinical Safety Pharmacovigilance job in Basking Ridge Full Time

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

This position will provide Daiichi-Sankyo strategic leadership and job support on aggregate safety reporting in Clinical Safety and Pharmacovigilance (CSPV). CSPV is undergoing globalization and has engaged a global CRO to manage aggregate reporting (AR) for its portfolio. This position will lead AR full-time management on how best to leverage and optimize a CRO relationship so that high quality documents are produced in a timely manner, while being consistent with internal requirements and health authority regulations and guidance. This would include harmonizing processes and procedures across DS regions and further realizing synergies across these regions. This colleague will also perform internal tasks that may be needed to grow and maintain a highly functional AR team.

Responsibilities

– Aggregate Report Generation: Spearhead AR management on strategic direction and the processes and internal and external staff involved in developing aggregate reports (including DSURs, PBRERs and ASRs, amongst others). Works deliberately to ensure adequate staff is engaged to fulfill AR regulatory requirements and timelines. Realizes internal synergies across DS regions and AR types (DSUR vs PBER). Helps to manage and distribute AR schedule in collaboration with other internal DS departments (Regulatory Affairs, Clinical Operations, etc.). Directly project leads preparation and submission of some ARs from an internal DS perspective.
– Aggregate Report Compliance: Owns expert management and supports AR compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance for ARs. Helps to enhance quality systems and procedures for the AR activities to assure regulatory compliance and meet regulatory reporting timelines. Works with AR team to assure the quality of the material content of any documents sent to regulatory authorities. Assists in providing AR compliance metrics to management.
– Aggregate Report Vendor Management: Owns and spearheads advice and support to maintain oversight of vendor(s) sourced to prepare and complete ARs. May perform training, mentoring onboarding of vendors as needed. Ensures vendor compliance with DS procedures.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

– Bachelor’s Degree Health Care or Life Science required
– Master’s Degree preferred

Experience Qualifications

-7+ years of professional experience in pharmacovigilance required
-7+ years of extensive experience preparing and submitting aggregate reports (including DSURs, PBRERs and ASRs) required
-4+ years of demonstrated ability to successful lead direct reports and other team members in a matrixed environment and/or involving a CRO
-4+ years of professional project management experience preparing and submitting aggregate reports in collaboration with a CRO
-4+ years of proven knowledge of document management systems like Veeva

Travel

Ability to travel up to 10% Domestic or international travel

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.