Senior Scientist, Drug Safety

Work Requirement

This role will be based out of our Redwood City, CA office and is hybrid with a minimum of 3 days per week onsite. 

Key Responsibilities

• Support Safety strategy for multiple or complex periodic regulatory documents according to the agreed process and timelines.
• Responsible for managing Safety Strategy and Management for complex and/or multiple products.
• As a Safety expert supports presentation of complex issues to Safety Review Committee (SRC).
• Establishes, reviews and updates department procedures and SOPs.
• Leads negotiations and provides expertise to the drug safety component of contracts/agreements with third parties to ensure quality and integrity of agreements.
• Key member of the Safety Management Team including setting agenda, producing necessary data outputs, facilitating discussions, and documenting conclusions
• Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g., Developmental Core Safety Information [DCSI] Company Core Safety Information [CCSI], Investigator Brochure [IB], etc.); co-ordinates meetings and tracks timelines to ensure completion 
• Support responses for regulatory or other ad-hoc safety queries in collaboration with Safety head ; includes proposing response strategies, review of relevant data, and authoring of responses
• Collaborate with other applicable functional area specialists including with Clinical Research, Regulatory Affairs, Biostatistics and Data Management, Translational Medicine, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs), business partners and other entities, as needed, to evaluate and manage safety signals for ZW products; provide support to cross-functional ad-hoc teams set up to address urgent and important safety issues
• Contribute to the preparation and review of safety risk section(s) of Investigator brochures (IBs), protocols, informed consent/assent forms, clinical study reports/synopses, Integrated Summary of Safety)/Common Technical Document (CTD) submissions and other documents as needed; ensure risk-reduction strategies are implemented timely and appropriately in relevant documents
• Maintain knowledge of  therapeutic area(s) for assigned products
• Identify opportunities for, or the need to, enhance existing processes through knowledge of internal and external environment
• Demonstrate knowledge and ensure compliance with current and applicable global PV regulations/guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.) and with corporate and departmental policies and procedures
• Synthesize data from multiple sources and critical thinking skills as well as authoring monthly signaling reports
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
   

Education and Experience

• Healthcare Professional degree required (e.g. RN, PharmD, PA) minimum of one year post-graduate clinical experience and 5 years of Drug Safety experience preferred.
• Advanced Patient Safety and/or Clinical/Drug Development experience of leading safety &/or scientific activities, across at least 4 of the following areas:
  • Clinical drug development (Early and/or Late Phase: develop program level safety strategy, including proactive risk identification & mitigation planning)
  • Periodic Safety Reports (establish and lead strategy, preparation and authoring)
  • Risk Management Plans (establish SOPs and lead strategy, preparation and authoring)
• Demonstrated ability to handle more than one complex project simultaneously, prioritizing well and recognizing key issues
• Excellent knowledge of MedDRA coding and WHO Drug coding 
• Hands-on experience with adverse event case processing in Argus/Aris-G database 
• Pharmaceutical industry experience desirable in Safety Scientist/PV Risk Management role
• Previous experience in oncology therapeutic area, especially with immunotherapeutic or antibody drug conjugates, is preferred
• Ability to work effectively in an advanced matrix structure

Skills and Abilities:

• Ability to apply principles, concepts and industry best practices governing pharmacovigilance and risk management in assigned projects.
• Excellent verbal and written communication skills, as well as presentation and team-interaction skills are necessary.
• Proficiency in Microsoft Office.
• Efficient in time management and multi-tasking.
• Strong organizational skills, including the ability to prioritize independently with minimal supervision