Job Description
Product-level safety ownership
Perform and lead signal detection, evaluation, validation and escalation activities for assigned product(s). Set the strategy for safety signal detection methodology, signal tracking and oversight of safety signals for assigned products. Drive, perform and document benefit‑risk evaluations and ensure appropriate risk‑management strategies are implemented. Lead and perform assessments for the preparation, review and approval of key safety deliverables (e.g. PSURs, DSURs, RMPs, regulatory responses). Translate safety data insights into actionable recommendations for product‑level benefit–risk discussions and regulatory interactions. Lead the clinical safety science interactions with partner companies for the assigned products (if applicable) ensuring sharing of safety information per the SDEA and the set up and collaborative functioning of the JSMT. Provide safety scientific input to ISS Evaluation Committee as required. In case of product qu...