Job Description Drug Safety function within BicycleTX provides clinical safety and pharmacovigilance support to medicines across life cycle. Reporting to the Head of Drug Safety, this key role will lead the clinical safety activities for the assigned compounds within the organization. You will be accountable for the implementation, execution, and management of clinical safety and risk management activities for assigned compounds in conjunction with the Company's development and planned commercial activities, industry standards, and compliance with global regulations. You will be a recognized expert in drug safety with considerable regulatory filing experience and will be expected to work independently and to take accountability for the drug safety deliverables for the assigned molecules. Key Responsibilities Develop and maintain an expert understanding of the safety profile of the assigned products as well as understanding of the relevant strategic context (e.g disease under study, safety profile of competitors, mechanism of action) Accountable for safety risk management activities for assigned product(s) in-development including defining and characterizing the safety profile (Adverse Events of Special Interest (AESIs), risk assessment/mitigation and risk management) Provide expert safety input and review of study specific documents (e.g. protocols, IBs, IMPDs, clinical study reports, INDs, CTAs). Accountable for safety sections of regulatory documents, including but not limited to BLA/MAA/NDA, EU Risk Management plans/REMS. In collaboration with external PV vendors and study Medical Monitor, provide oversight of clinical safety activities including medical review and assessment of SAEs, preparation of analyses of similar events (AOSE) for unexpected and related serious adverse events (SUSARs) from clinical trials. Lead safety evaluation activities including First in Human (FIH) studies in collaboration with internal cross functional experts and external vendors. Ongoing signal detection, evaluation, and periodic review of emerging safety data (e.g AEs, SAEs, Labs), assess for safety trends, and timely presentation of important/urgent safety issues together with risk communication/management strategy to the company senior management including Drug Safety Committee (DSC), other internal and external stakeholders (e.g Independent Data Safety Monitoring Boards). In collaboration with internal and external stakeholders, direct the development, preparation, and compliance of periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings), safety communications, product labelling/package inserts and other reports, as necessary Respond to safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans Effectively represent ‘Drug Safety’ function across various cross-functional teams including Global Program Team (GPT) Assist in preparation/update of safety related global SOPs to ensure the efficient operation of the drug safety function.