Job Description

Position Title: PV SCIENTIST [ Review Signal/Aggreegrate Analysis]

Assignment Duration: 2+ Months

Position Summary: Lead identification, analysis, and evaluation of safety signals to assess their impact on product safety profiles and recommend actions.

Key Responsibilities:

Signal and Safety Data Evaluation

• Lead the identification, analysis, and evaluation of safety signals
• Define data acquisition strategy, methodology, and approach for safety evaluations
• Perform analysis of safety data and lead authoring of safety assessment
• Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendation for action and initiate proposal for Safety Management Team
• 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)
• 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
• Lead signal assessment documentation following signal management and safety governance framework

Clinical Trial Support

• 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, Safety Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project/study documents and answer ad-hoc safety queries from ethics committees
• Support ad-hoc review of the Safety Management Plans

Risk Assessment, Regulatory Inquiries, and Periodic Reporting

• Lead 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)
• Lead strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs

Qualification & Experience:

• Phase 1-3 clinical study experience
• Protocol, IB, ICF development
• SMC, DMC
• SAE and aggregate data review and analysis
• Signal detection and signal evaluation
• DSUR authoring
• PharmD, NP, RN, or PhD in a medical field or biological science and 8+ years of experience as a Safety (Pharmacovigilance) Scientist

Notes:

• Feedback from Manager:
• Focus on candidates with experience in signal detection/management and aggregate reviews (not individual case processing).
• Aggregate analysis of safety data/comprehensive evaluation of safety information.
• Lead (responsible for) signal detection/monitoring.
• Self-sufficient and proactive.

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