Director Clinical Safety

Location
Basking Ridge
Posted
May 04, 2022
Ref
11038BR
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

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

Our Director, Clinical Safety role is on our global CSPV team and is responsible for the post-marketing Pharmacovigilance surveillance of assigned product.  Incumbent will be responsible for responses to Health Authority inquiries on safety issues and prepares safety data for health authority review boards.

Present safety data in SMTs as a recognized product safety expert and serve as the CSPV functional rep at Global multifunctional project team meetings. This position prepares, summarizes, and reviews aggregate safety analyses.  Additionally, this position develops and implements integrated project/product risk management strategies and drafts the Risk Management Plan with Level III. 

This position performs safety assessments and determines the safety profiles of assigned products.  This position also works with other CSPV staff to assess new signals/risks emerging from post marketing data.  This position may review and approve safety documents.

Provides integrated safety input into all safety relevant parts of regulatory documents (IB, CCDS, RMP, REMS, DSUR, PSUR, SmPC, PI, CSR, Clinical Overview and Integrate safety summary) required during active development, submission phase and during marketing phase.

 
RESPONSIBILITIES
 1. Safety Expert – Overall: Serves as the physician responsible for safety profile and for leading SMTs for post marketing safety data from assigned products. Defines the risk component of the B/R assessment. Has good working knowledge of regulations and guidance related to safety reporting and safety surveillance.
2. Safety Expert – Signal Identification: Performs more advanced aggregate signal identification activities formulated by manager.
3. Safety Expert – Signal Evaluation: Assists manager in assessing signals by surfacing and assembling relevant data and conducting analyses of datasets.
4. Safety Expert – Risk Mitigation & Communication: Supports manager in recommending and implementing risk mitigation activities. Proposes risk mitigation solutions to management and SMT.
5. Reports and Submissions: Contributes to and reviews safety sections of the NDA, CSR, and IB. May first author white papers involving safety. Provides medical review for US and EU periodic reports. Co-owns RMP with manager.
 
QUALIFICATIONS
 Education and Experience

MD degree required

  • 3-5 years of Pharmacovigilance (PV)/drug safety experience in pharmaceutical drugs either from relevant work experience within the industry or related healthcare work.
  • Demonstrated ability to prioritize work, implement strategy and processes, collaborate with others.

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.

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.