Department: Drug Safety
Reports To: Director, Drug Safety Operations
- BS degree and Minimum of 7+ years of relevant experience within the biotech/biopharmaceutical industry with a working knowledge of drug safety and risk management, and an overall understanding of drug development, pharmacology, ICH, FDA, EMA and Asia/Pacific PV requirements
- Previous people management skills highly preferred.
Hours: 40 hours/week
Over-time may be required on occasion
Oversight of CRO responsible for global SAE case processing and submissions.
Essential Functions of the job:
- Weekly and ad hoc meetings with the CRO
- Review feedback and performance metrics relating to the CRO for proactive identification and management of potential safety issues
- Collaborate with CROs on any late report corrective action & preventive action (CAPA) plans in order to address delays in reporting in a timely manner
- Ensures CRO is meeting specific drug safety data and quality targets for case handling and/or global submissions.
- Ensures CRO is compliant with all global reporting requirements to business partners, ethics committees and global regulatory authorities.
- Serves as the lead Drug Safety representative for various cross-functional clinical study teams
- Participates in training investigators on SAE reporting obligations at study kick off meetings
- Assists head of Drug Safety Operations with establishment and ongoing review of Key Performance Indicators (KPIs) for the CRO
- Participates in the review and approval of program-specific Safety Management Plans
- Oversees individual team activities as it relates to global SAE case management and global submissions activities.
- Collaborates closely with head of Drug Safety Operations & Medical Safety team to develop Drug Safety SOPs
- Responsible for timeline management and ensuring global submission of aggregate safety reports and line listings such as DSURs and other aggregate safety reports (e.g.; PSURs/PBRERs) as required
- Oversees SAE reconciliation activities on a regular basis, and ensures that CRO is processing and reconciling SAEs across BeiGene clinical trials as per study timelines and per contract
- Manages communication and timelines with applicable partner companies, collaborative sponsors and respective CROs regarding the intake, case processing, medical review and global submission of ICSRs as well as global safety aggregate reports (expedited reports, DSURs, CIOMS II line listings)
- Liaises with various internal and external groups to maintain a high level of quality and consistency across functional teams on best practices and industry standards.
- Maintains currency with evolving international guidance and regulations for global safety reporting, safety surveillance and risk management in both a clinical and post-marketed setting (FDA, EMA, CFDA/SFDA, and other Asia/Pacific territories)
- May provide back up support for other Drug Safety Operations Managers as well as Head of Drug Safety Operations
- Actively participate in Drug Safety inspection readiness activities or regulatory inspection requests or interviews as needed
- 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
- Excellent computer skills in Microsoft environment (Microsoft Excel, Power Point, SharePoint and Word).
- Strong experience with electronic data capture (EDC) and knowledge of clinical trial data management principles
- Argus Safety database and data entry and global submissions expertise required
- Understands safety database structures and is familiar with data retrieval tools, and coding dictionaries such as MedDRA, WHODrug).
- Experience developing and revising Drug Safety/PV SOPs
- Understanding of medical terminology and the ability to summarize medical information required
- Knowledge and experience with global safety reporting and regulatory compliance and experience with international safety reporting/regulations in both clinical development phase as well as a post-marketed safety setting (e.g.; FDA, EMA, China, New Zealand, Australia)
Supervisory Responsibilities: Will directly supervise staff as they are hired into the organization
Demonstrates initiative, teamwork and accountability
- A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strict timelines is required.
- Self-motivated and capable of working independently
- The ability to provide direction to a team, and to influence peers and team members
- Ability to effectively represent Drug Safety Operations on multidisciplinary teams; ability to evaluate and analyze procedural gaps
- An excellent global pharmacovigilance knowledge base.
Excellent project management skills with the ability to align internal and external resources
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 : Efficient in Microsoft Word, Excel, and Outlook
Other Qualifications :
BeiGene USA, Inc. is an Equal Opportunity Employer welcoming diversity in our workforce. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring, and promotion practices are performed without regard to the above-listed items.