Associate Director, Safety Scientist

BeiGene

22h•Hybrid

About The Position

This role will focus on early development (phase I) and late stage (phase II-III) safety science activities. 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 Science group as part of a matrix team to conduct safety assessment and safety risk management activities, based on ICH standards. The person in this position provides safety expertise for assigned developmental and/or marketed products in conjunction with Product Safety Physician Leads (PSLs) and Safety Physicians. Represents GPS department internally and externally at a global level and functions as an authoritative and professional member of relevant teams. Leads signal evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and interactions.

Requirements

PharmD or PhD in a medical field or biological science and 4+ years of experience in pharmacovigilance in an analytical role
RN with 8+ years in pharmacovigilance in an analytical role.
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
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.
Intermediate knowledge working with a safety database for retrieval of safety information.
Advanced knowledge of MedDRA.
MS Office Suite: Advanced application capability with Excel, PowerPoint, and Word.
Familiarity with data mining tools and exploratory analyses tools such as Spotfire.

Nice To Haves

2+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.

Responsibilities

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 and applicable regulations.
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 Investigational 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
Any other tasks assigned by manager to assist in departmental activities