Safety Science, Associate Manager
Location: Bangalore
Category: Clinical
Job ID: 25718
Company: Fortrea
Company Overview
Fortrea is a leading global contract research organization (CRO) providing clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in ~100 countries, Fortrea is transforming drug and device development to improve patient outcomes worldwide.
Role Overview
The Safety Science, Associate Manager is responsible for overseeing Pharmacovigilance (PV) and Patient Safety Solutions (PSS) operations, managing adverse event reporting, ensuring regulatory compliance, and leading a team to deliver high-quality safety data management. The role involves line management, risk assessment, data analysis, and regulatory reporting.
Key Responsibilities
Team Leadership & People Management
Line-manage PSS staff, conducting performance reviews and addressing human resource issues.
Assign project resources and manage workload distribution.
Train, mentor, and develop junior team members in pharmacovigilance and regulatory reporting.
Manage performance appraisals and provide career development guidance.
Ensure team members’ training records are up to date.
Pharmacovigilance & Safety Data Management
Oversee receipt, processing, and tracking of adverse event (AE) reports from clinical trials and post-marketing sources.
Ensure timely and accurate Individual Case Safety Reports (ICSRs) processing.
Manage Expedited Safety Reports (ESRs), ensuring regulatory submission within stipulated timelines.
Conduct quality review of safety data, including narrative writing, MedDRA coding, and expectedness/listedness assessment.
Ensure appropriate medical review of adverse event cases.
Oversee reconciliation of SAEs between clinical trial and safety databases.
Regulatory Compliance & Risk Management
Ensure compliance with global safety reporting regulations (FDA, EMA, ICH-GCP, EudraVigilance).
Manage safety reporting to global regulatory agencies, ethics committees, and investigators.
Prepare and participate in regulatory audits and client inspections.
Contribute to the development of pharmacovigilance reports, aggregate reports, and risk management plans.
Process Improvement & Stakeholder Collaboration
Identify process inefficiencies and propose solutions using LEAN/Six Sigma methodologies.
Maintain knowledge of Fortrea’s safety database conventions and other client safety databases.
Collaborate with cross-functional teams (Data Management, Regulatory Affairs, Medical Affairs, and Project Management).
Provide safety presentations for client capabilities meetings and internal teams.
Support business development efforts by contributing to proposal writing and cost estimation.
Required Qualifications & Experience
Education:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
Equivalent experience may be considered in place of formal education.
Experience:
7–10 years of experience in Pharmacovigilance/Safety Science, including 2+ years in a leadership role.
Experience in clinical trial safety, case processing, signal detection, and aggregate reporting.
Knowledge of global PV regulations (FDA, EMA, ICH, MedDRA, EudraVigilance).
Familiarity with Medical Device Reporting (MDR) and Risk Management Plans (RMPs) is a plus.
Skills & Competencies:
Strong leadership and team management abilities.
Excellent analytical, problem-solving, and risk assessment skills.
Proficiency in safety databases and MedDRA coding.
Excellent verbal and written communication skills.
Ability to prioritize tasks and manage multiple projects in a fast-paced environment.
High level of attention to detail and regulatory compliance awareness.
Preferred Qualifications
EudraVigilance certification.
Experience in aggregate reporting and medical device safety.
Work Environment & Travel Requirements
Hybrid work model with office location in Bangalore.
Available for 10% travel, including overnight stays for client meetings, audits, or regulatory inspections.
About Fortrea
Fortrea is committed to advancing clinical trials and patient safety through scientific innovation. We foster a collaborative and inclusive work environment, empowering professionals to make a global impact.
Equal Opportunity Employer Statement
Fortrea is an Equal Opportunity Employer (EOE/AA) and does not tolerate discrimination based on race, gender, disability, veteran status, or any other legally protected category.
For more details, visit www.fortrea.com.
If you require accommodations during the hiring process, please contact taaccommodationsrequest@fortrea.com.
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