- Identify, analyze, and evaluate safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile
- Support and propose data acquisition strategy, methodology, and approach for safety evaluations
- Analyze safety data and author safety assessment reports.
- Collaborate with PSLs, scientists, pharmacoepidemiologists, and other cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy
- Execute signal assessment strategy and prepare presentations for Safety Management Team and Company Safety Committee
- Prepare and present safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)
- Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions
- Apply effective communication skills to lead and facilitate safety team meetings
- Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner
- Support the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator's Brochure, Healthcare Professional communications [DHCP letter or DHPC], Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members
- Perform signal detection and signal assessment along with required documentation following BeiGene process
- Conduct review of safety data and monitor the safety of patients on allocated clinical trials
- Author and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, SAPs/ TFLs, Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees
- Author safety sections and review aggregate reports, e.g., PBRERs, DSURs, PADERs
- Support the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with Safety Physicians and other CST members
- Support the authoring of Storyboards and Briefing Books for HA interactions
- Assist with writing and maintenance of the Safety Management Plans
- Support investigator training
- Analyze safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/Periodic Adverse Experience Report (PAER), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs)
- Assist with integrated Benefit/Risk assessments
- Any other tasks assigned by manager to assist in departmental activities
- The position has no direct reports. The Senior Manager, Safety Scientist is part of a team that performs highquality and timely scientific and operational safety analysis. This position works closely with the Safety Scientistgroup as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGeneprocess and applicable regulations.
- Prior experience as a safety scientist
- Pharmaceutical product development experience
- Experienced in global regulatory requirements for pharmacovigilance
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Senior Manager, Safety Scientist - Emeryville, United States - BeiGene
Description
General Description:
_The person in this position provides safety expertise for assigned compounds with Product Safety Physician Leads (PSLs).
Represents GPS department internally and externally at a global level and functions as an authoritative and professional member of relevant teams.
Supports signal evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and interactions._Essential Functions of the Job:
Signal and Safety Data Evaluation
Clinical Trial Support
Risk Assessment, Regulatory Inquiries, and Periodic Reporting
Promote and Advance the Field of Pharmacovigilance
Supervisory Responsibilities:
Project Management - Communicates changes and progress; Completes projects on time and budget.
Computer Skills: Knowledge working with a safety database for retrieval of safety information; Intermediate knowledge of MedDRA; Advanced application capability with Excel, PowerPoint, and Word. Familiarity with data mining tools and exploratory analyses tools such as Spotfire.
Other Qualifications:
Travel: Less than 10%
Competencies:
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
