Department: Pharmacovigilance & Drug Safety
Reports To: Jean Ohara (Sr. Manager, PV Training & Quality Management)
- BS/BA degree required with at least 5-7 years of relevant experience within the biotech/biopharmaceutical industry.
- Combined experience and overall understanding of PV, Regulatory Affairs, Clinical research and/or Compliance preferred.
- Strong attention to detail and the ability to multi-task in a fast-paced environment
- Strong interpersonal and communication skills and the ability to effectively work individually, within a cross-functional team, as well as with external partners, vendors and overseas colleagues.
Works with PV and Drug Safety team to ensure compliance of pharmacovigilance activities
Contributes to PV aspects of clinical trial activities
Assists in the coordination and support of global PV internal audits and/or regulatory inspections
Essential Functions of the job:
- Works with the Sr. Manager and other PV/Drug Safety Operations team members to establish global PV inspection/audit inspection readiness plans
- Assists in PV quality & compliance oversight both internally and across third parties (e.g. safety CRO, study CROs, and other parties submitting or exchanging safety data with BeiGene).
- Assist in the development and training of department-specific SOPs and Work instructions
- Supports the conduct of Pharmacovigilance system audits globally for both post marketed and clinical development products, to assure compliance with the Code of Federal Regulations, EU CT Directive, local Asian regulations, ICH, global Safety Data Exchange Agreements (SDEAs), and BeiGene PV policies and procedures.
- Supports PV regulatory inspections (FDA, EMA, CFDA, etc.) and/or partner audits
- Assists in the tracking of PV corrective and/or preventative actions (CAPA) plans
- Contributes to the development of PV process improvement procedures, directives or initiatives that enhance regulatory compliance and global PV efficiencies
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.
- Proficiency with Microsoft Suite of products and Adobe Acrobat. Skills in Microsoft Project, Microsoft Visio, Microsoft SharePoint and Veeva a plus
- Strong analytical skills & preferably experience with Argus safety database, MS Excel, Spotfire, Tableau or other tools used to summarize PV compliance metrics
- Ability to handle multiple projects at once, and to accommodate meetings scheduled globally (e.g.; US, EU, Asia/Pacific and/or Latin American regions)
- Knowledge of Oracle Argus safety database workflows is strongly preferred.
Travel: Less than 10%