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Safety Sciences Lead

Safety Sciences Lead

ConfidentialHyderabad / Secunderabad, Telangana
30+ days ago
Job description

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

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    Science Lead • Hyderabad / Secunderabad, Telangana