- Lead the identification, analysis, and evaluation of 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
- Propose and lead data acquisition strategy, methodology, and approach for safety evaluations
- Lead analysis of 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 analysis per strategy and assist with the preparation of presentations for Safety Management Team and Company Safety Committee
- Lead the preparation and presentation of 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
- Lead 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
- Lead the review of safety data and monitor the safety of patients on allocated clinical trials
- Lead the writing 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
- Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General lnvestigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with Safety Physicians and other CST members
- Lead the authoring of Storyboards and Briefing Books for HA interactions
- Lead with writing and maintenance of the Safety Management Plans
- Lead Safety Science specific investigator training
- Lead the analysis of 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)
- Contribute to integrated Benefit/Risk assessments.
- Any other tasks assigned by manager to assist in departmental activities.
- Prior experience as a safety scientist
- Pharmaceutical product development experience
- Experienced in global regulatory requirements for pharmacovigilance
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Associate Medical Director, Safety Physician - 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
Supervisory
Responsibilities:
The position has no direct reports.
The Associate Director, Safety Scientist is part of a team that performs high quality and timely scientific and operational safety analysis.
This position works closely with the Safety Scientist group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations.
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.
Education
Required:
PharmD or PhD in a medical field or biological science and 4+ years of experience in pharmacovigilance in an analytical role
OR
RN with 8+ years in pharmacovigilance in an analytical role.
OR
MD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring.
4+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine and 2+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.
US trained physicians must have achieved board eligibility or certification.Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Safety Officer or appropriate delegate.
Other
Qualifications:
Travel: Less than 10%
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.
