Department: Pharmacovigilance and Drug Safety
Manages the Safety Operations staff of Asia Pacific region including safety operations in support of marketed products managed through the Shanghai office. Provides regional support for all ICSR management and associated internal and external queries in close coordination with global safety operations.
Essential Functions of the job:
- Oversees team activities as it relates to global SAE case management and global submissions activities required within Asia/Pacific region.
- Collaborates closely with global head of Drug Safety Operations & Regional PV Head of Asia Pacific to ensure compliance with Asia/Pacific PV requirements, but also ensuring alignment with global PV team procedures
- Responsible for coordination of timelines and gathering information required for DSURs, PSURs, J-PSURs and other regional safety line listings/reports due for submission
- Manages communication and timelines with applicable partner companies, collaborative sponsors and respective CROs as required within Asia/Pacific region (China, Japan, S. Korea, Australia, New Zealand)
- Liaises with various departments in the management of high level of quality and consistency across PV safety data & best practices
- Maintains currency with evolving international guidance and regulations for global safety reporting, safety surveillance and risk management on behalf of all Asia/Pacific territories
- May provide back up support for other Drug Safety Operations Managers as well as Head of Drug Safety Operations
- Able to support requests for PV/Drug Safety inspection requests both in clinical and post-marketed setting (particularly as it relates to CFDA, PMDA, MFDS and TGA)
- Solutions-oriented individual with a keen eye towards solutions to serve regional office, and also to support global PV strategies/timelines and procedures
All Safety Operations staff in the Asia Pacific region including oversight of regional vendors and partners
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
Computer Skills :
Excellent computer skills in Microsoft environment (Microsoft Excel, Power Point, SharePoint and Microsoft Word).
Other Qualifications :
- Able to adjust to multiple demands and shifting priorities and react constructively in a high-energy, fast paced environment
- Excellent interpersonal and communication skills, both written and oral
- Experience developing and revising Drug Safety/PV SOPs
- Understanding of medical terminology and the ability to summarize medical information required
- Knowledge and experience with Asia/Pacific regional PV/safety reporting requirements and ability to train and mentor more junior staff in clinical trial safety principles, but also preferably in preparations for product launch/post-marketed safety commitments
- Strong leadership skills and ability to support a unified global PV message/set of policies
- Ability to effectively represent PV/Drug Safety Operations on multidisciplinary teams; ability to evaluate and analyze procedural gaps
- An excellent global pharmacovigilance knowledge base.
- At least 5 years’ experience managing a safety operations group
Travel: Regional travel as required. 10% or less.