Director Safety Risk Management

Role Overview: As a Director of Safety Risk Management in the Healthcare/Lifesciences industry, you will work on the drug safety (pharmacovigilance) team, focusing on understanding the end-to-end PV lifecycle. Your expertise in ICSRs, Periodic reports, and Signal Management processes will be crucial. Leading and guiding RMP and aRMM processes, along with interacting with stakeholders, will be part of your responsibilities. Defining processes, utilizing swim-lane diagrams, and staying updated with regulatory changes are key aspects of the role. Key Responsibilities: - Discussing gaps and pain points with business users and translating customer needs into solutions for BRM/RMP and aRMM processes. - Collaborating with UX and Development teams to understand design and technology implications, execute the product roadmap, and develop new features. - Managing the product backlog, planning release plans, and ensuring team completion of Release/Sprint Goals. - Researching market trends, analysing user feedback, and maintaining product performance tracking. - Staying updated with Agile/Scrum best practices and industry trends. Qualifications Required: - Bachelor's degree in science or engineering. - Senior-level experience in the Pharma industry or as a Regulatory inspector. - Mastery knowledge of regulations related to the product portfolio. - Technical aptitude and excellent communication skills. - Strong time management, organizational skills, and attention to detail. - Knowledge of PV systems like Argus and ArisG will be advantageous. [Note: No additional details about the company were provided in the job description.],