Safety Reporting Specialist – Pharmacovigilance
Job ID: R-01335773
Job Type: Full-Time
Category: Clinical Research / Pharmacovigilance
Work Mode: Fully Remote
Location: Bangalore, Karnataka, India
Job Overview
A leading global contract research organization (CRO), part of the PPD® Clinical Research portfolio at Thermo Fisher Scientific, is seeking a Safety Reporting Specialist to support global pharmacovigilance and safety reporting activities. This role is ideal for professionals with hands-on experience in regulatory safety reporting who can manage submissions, ensure compliance with global regulations, and contribute to process excellence within a collaborative, international environment.
As a Safety Reporting Specialist, you will be responsible for the preparation, submission, and oversight of safety reports in accordance with global regulatory timelines and country-specific legislation, while serving as a key point of contact for assigned projects.
Key Responsibilities
Receive, prepare, and submit safety reports to regulatory authorities and other applicable stakeholders
Ensure all safety reports comply with global regulatory timelines, country-specific legislation, and internal SOPs
Lead large-scale safety reporting projects, ensuring accurate and timely submissions in line with agreed processes
Monitor reporting timelines and compliance metrics on an ongoing basis
Provide input and feedback to support the development and continuous improvement of program-level and departmental procedural documents
Actively contribute ideas for process enhancements and participate in their implementation
Collaborate with cross-functional teams, including pharmacovigilance, clinical operations, and regulatory affairs
Represent the safety reporting function in internal and external meetings as required
Serve as a primary departmental contact on assigned projects, coordinating with internal and external stakeholders
Mentor and provide guidance to junior team members and new joiners
Generate safety reporting metrics and contribute to project-level tracking and financial activities, as applicable
Business & Stakeholder Engagement
Act as a key interface for safety reporting on assigned projects
Interact with internal and external stakeholders on complex safety-related matters requiring cross-functional coordination
Build professional relationships with senior internal and external personnel within the pharmacovigilance domain
Education & Experience Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related discipline
Minimum 2+ years of relevant experience in safety reporting, pharmacovigilance, or clinical research within a CRO or pharmaceutical environment
Equivalent combinations of education, training, and relevant experience may be considered
Required Knowledge, Skills & Competencies
Strong knowledge of medical terminology and pharmacovigilance concepts
Thorough understanding of global safety reporting requirements and applicable regulations
Excellent proficiency in Microsoft Office applications and good understanding of safety databases and reporting systems
Strong knowledge of SOPs, procedural documents, and regulatory compliance frameworks
Excellent time management and multitasking abilities in a deadline-driven environment
High attention to detail and strong quality focus
Demonstrated critical thinking and problem-solving skills
Ability to influence and communicate effectively across all organizational levels
Proven ability to work collaboratively in a global, cross-functional team environment
Initiative-driven mindset with persuasion and negotiation skills
Ability to mentor and support junior colleagues in safety reporting activities
Why Join This Organization
Work on global clinical research and pharmacovigilance programs with international exposure
Strengthen expertise in regulatory safety reporting and compliance
Collaborate with multidisciplinary teams across regions and functions
Gain career development opportunities within a globally recognized CRO environment
Contribute directly to patient safety and regulatory excellence
About Thermo Fisher Scientific – PPD®
Thermo Fisher Scientific is a global leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through its PPD® Clinical Research Services, the organization supports clinical development programs across 100+ countries, delivering laboratory, digital, and decentralized clinical trial solutions.
Thermo Fisher Scientific is an equal opportunity employer committed to diversity, equity, and inclusion.
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