We are seeking a Safety Sciences Lead to provide direction, strategy, and leadership for signal detection and management activities at our India site. This role requires a medical professional with extensive experience in global Pharmacovigilance (PV) . You will be responsible for leading and managing a team of safety professionals, ensuring alignment with global goals, and fostering a culture of continuous improvement.
Roles & Responsibilities
- Leadership & Strategy : Provide strategic direction and leadership for all signal detection and management activities. You will be accountable for achieving the goals of the Global Patient Safety ( GPS ) department and will participate in budget and headcount planning.
- Team Management : Provide managerial leadership to the safety sciences team, overseeing staff recruitment, retention, and professional development. You will ensure the team's compliance with corporate and departmental training requirements.
- Pharmacovigilance (PV) : Ensure smooth and collaborative interactions with all other Safety groups. You will provide relevant input on technical processes and contribute to continuous improvement initiatives across GPS .
- Collaboration & Communication : Establish effective and collaborative interfaces with partners outside of GPS , such as the technology team, to ensure signal management needs are met. You will communicate regularly with the global team to discuss product and process issues.
- Project Management : Lead or contribute to cross-functional initiatives aimed at improving pharmacovigilance capabilities related to signal management.
Qualifications
A medical degree with a minimum of 6 years of experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in both clinical trial and post-marketing environments.A minimum of 3 years of functional management experience overseeing PV staff.A thorough understanding of the global PV regulatory environment , with working knowledge of EU and US regulations, ICH guidelines, and GCP .A working understanding of drug safety databases.A demonstrated ability to provide critical and timely insight, and strong analytical problem-solving skills.The ability to negotiate a strategic position after taking feedback from multiple sources.Soft Skills
Leadership : Strong leadership skills and the ability to oversee multiple projects simultaneously.Problem-Solving : The ability to provide astute advice quickly in difficult scenarios.Communication : Excellent communication skills for regular interactions with global and cross-functional teams.Organization : The ability to successfully manage workload to timelines and a familiarity with basic project management tools.Adaptability : A high degree of adaptability to respond to and provide advice quickly to difficult scenarios.Skills Required
Leadership, Team Management, Pharmacovigilance, Project Management, Problem-solving, Adaptability