FSP - Associate Safety Specialist in भारत

Associate Safety Specialist role performing day-to-day pharmacovigilance activities within a regulated environment. Responsibilities include adverse event data management, case assessment, regulatory reporting, and collaboration with cross-functional teams to ensure patient safety.

Responsibilities

• Perform day-to-day pharmacovigilance activities including adverse event data entry, coding, and case assessment
• Review and maintain accuracy of safety cases and regulatory documentation for quality and consistency
• Prepare and maintain regulatory safety reports while staying current on applicable regulations and therapeutic areas
• Participate in on-call duties to ensure 24-hour case intake coverage from investigative sites as needed
• Collaborate with project teams, clients, investigators, and third-party vendors on safety information management

Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification
• 0–2 years of relevant pharmacovigilance or safety-related experience
• Strong critical thinking and problem-solving abilities
• Proficiency in English with medical terminology understanding
• Proficiency with Microsoft Office (Outlook, Word, Excel) and multiple databases
• Ability to manage competing priorities and meet strict deadlines independently
• Excellent attention to detail and written communication skills