Safety Scientist, Global Patient Safety
Duties: The Drug Safety Scientist is responsible for a variety of duties within the department. The role includes data review, document submissions, reporting and FDA correspondence. The Drug Safety Scientist will: Oversee the Adverse Events for OTC drug products as they comply with regulations Manage documentation for training and FDA correspondence Oversee medical assessments for related cases Be responsible for MedDRA coding in related to Adverse Events Execute Quality Assessments on urgent MedWatch Reports Investigate complaints and take proper, thorough steps in this process Liaison with outside contacts including physicians as needed Monitor trends, analyze and aggregate data Troubleshoot any issues that are consistent or unusual in the database The Drug Safety Scientist will: Experience in Drug Safety, Adverse Events, Vigilance or related areas in the consumer healthcare arena Medical Assessment & Medical Terminology experience Case Processing experience Knowledge in the following areas: MedWatch Reports, Sharepoint Files, MedDRA coding Experience with Regulatory guidelines and FDA submissions Strong communication and organization skills Experience with OTC Drugs and/or cosmetics Education: Doctorate in Pharmacy, Registered Nurse, Registered Pharmacist Skills: 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. Functions of the Job:
- Monitor the safety of patients on allocated clinical trials
- Write 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
- Collaborates with Data Analytics, Biostats and Data Management to ensure that outputs of safety data from both safety and clinical trial databases meet the need for preparation of aggregate safety reports including DSUR, PBRER and other required aggregate safety analyses required by regulatory authorities
- Contribute to safety sections and review aggregate reports, e.g., PBRERs, DSURs, PADERs
- Write and review safety sections of regulatory submissions, as appropriate, collaborating with Product Safety Physicians and other CST members
- Assist with writing and maintenance of the Safety Surveillance Plans
- Assist with integrated Benefit/Risk assessments
- Participate in safety surveillance, coordinating aspects of signal evaluation/safety review activities e.g., Scheduled review of scientific literature, SAE listings, data-mining and data outputs from the safety database and also data outputs from the clinical database to identify potential risks, emergent safety issues and signals
- Participate in evaluation of safety topics and issues and write safety signal detection and assessment reports, working with the PSL and Signal Detection Team
- Write and maintain RSI, CCSI and contribute to safety summaries to support changes to the CCDS and PI/ SmPC Type II variations including drafting justification documents and regulatory responses
- Contribute to writing and maintenance of core RMPs and local Risk Management Plans/ REMS
- Assist in the internal and external dissemination of important new safety information or actions (e.g., DHCP/DHPC letters)
- Maintain and enhance knowledge of safety profiles for allocated products, including both BeiGene and competitor products
- Any other tasks assigned by manager to assist in departmental activities
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