Manager, Global Safety Submissions
Posted on Apr 5, 2021 by BeiGene, Ltd.
Works under the direction of the Global Safety Submissions lead to execute the strategy and processes defined for monitoring and submitting individual case safety reports & aggregate safety report submissions to regulatory authorities, investigators & ethics committees for BeiGene's marketed & investigational products.
Essential Functions of the job:
Works with direct manager and other Global Patient Safety team members to execute submissions processes for generating, quality review, submitting, and tracking expedited individual case safety reports (ICSR) and aggregate safety report submissions to regulatory authorities and other applicable recipients for investigational and marketed products.
Assists in the production and review of submissions compliance metrics for ICSR and aggregate report submissions to regulatory agencies, partners, ethics committees and investigators.
Analyzes submissions metrics and trends to provide data driven strategic recommendations to the Global Safety Submissions lead.
Collaborates with Global Patient Safety, Clinical and Regulatory functions to ensure awareness and compliance of all safety reporting obligations to global regulators and partners.
May assist in the development and review of safety exchange agreements/plans with third-party vendors and business partners.
Collaborates with the BeiGene Safety Systems team to ensure the global safety database can support submission processes.
Provides support and assists with oversight activities of Contract Research Organizations (CROs) involved in safety reporting to local regulatory authorities, ethics committees and investigators.
May assist in the development and training of department-specific SOPs and Work instructions to ensure procedures are in place to support a global submissions process.
May support PV regulatory inspections (FDA, MHRA, CFDA, etc.) and/or partner audits.
Supervisory Responsibilities: Not Applicable
Knowledge, Skills and Education Required:
Bachelor's degree required with 5+ years of relevant experience within the healthcare industry, and at least 2 years of experience in safety/pharmacovigilance.
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.
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 (eg; US, EU, Asia/Pacific and/or Latin American regions)
Knowledge of Oracle Argus safety database workflows is strongly preferred.
Ethics- Treats people with response, Inspired the trust of others; Works with integrity and ethically Upholds organizational values.
Planning/Organization- 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 s 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.