Pharmacovigilance Services Associate Manager
Location: Bengaluru, India
Employment Type: Full-Time
Department: Pharmacovigilance / Drug Safety / Risk Management
Experience: 5–10+ Years
Qualification: MBBS / MD
Position Overview
We are seeking an experienced Pharmacovigilance Services Associate Manager to provide medical oversight for aggregate safety reports, Risk Management Plans (RMPs), signal management activities, and regulatory safety documentation. The role requires strong expertise in pharmacovigilance, benefit-risk evaluation, medical review, and regulatory compliance to ensure high-quality safety deliverables aligned with global regulatory requirements and client expectations.
The successful candidate will collaborate with cross-functional teams, provide scientific leadership, mentor team members, and support strategic pharmacovigilance initiatives while maintaining compliance with global health authority standards.
Key Responsibilities
Aggregate Safety Reports & Medical Review
Conduct comprehensive medical review of aggregate safety reports and Risk Management Plans (RMPs) within agreed timelines.
Ensure all safety documents are:
Medically accurate
Scientifically robust
Consistent across sections
Compliant with global regulatory requirements
Review and analyze cumulative safety data to assess the evolving benefit-risk profile of assigned products.
Provide medical interpretation and conclusions regarding product safety profiles.
Perform quality control (QC) review of aggregate reports and associated safety documents.
Risk Management Planning (RMP)
Review, analyze, and provide scientific input for:
Risk Management Plans (RMPs)
Risk Minimization Measures
Benefit-Risk Assessments
Safety Monitoring Activities
Ensure alignment with client processes, SOPs, and regulatory expectations.
Incorporate client and health authority feedback into RMP updates and associated documents.
Address regulatory authority queries and requests related to safety and risk management activities.
Signal Management & Safety Evaluation
Participate in signal detection, validation, assessment, and management activities.
Review emerging safety information from:
Aggregate reports
Clinical studies
Scientific literature
Pregnancy registries
Post-marketing surveillance data
Assess safety trends and identify potential risks requiring further evaluation.
Provide expert medical analysis and recommendations for signal evaluation reports.
Regulatory Compliance & Health Authority Support
Ensure compliance with:
Global Pharmacovigilance Regulations
Good Pharmacovigilance Practices (GVP)
ICH Guidelines
Client SOPs and Quality Standards
Address health authority comments and commitments from previous submissions.
Support preparation of responses to regulatory authority queries and ad-hoc requests.
Maintain inspection and audit readiness across safety deliverables.
Project & Stakeholder Management
Participate in:
Kick-Off Meetings (KOM)
Project Planning Sessions
Safety Strategy Discussions
Client Review Meetings
Collaborate with:
Pharmacovigilance Teams
Safety Physicians
Regulatory Affairs
Medical Writing Teams
Clinical Teams
Global Clients
Act as a key medical reviewer and subject matter expert for assigned projects.
Quality Management & Process Excellence
Ensure compliance with all Service Level Agreements (SLAs) and Key Performance Indicators (KPIs).
Identify and report:
Critical Deviations
Major Quality Issues
Minor Compliance Deviations
Support continuous quality improvement initiatives and process optimization efforts.
Contribute to development of best practices and standardization across projects.
Training, Mentorship & Knowledge Sharing
Mentor junior physicians, medical reviewers, and pharmacovigilance professionals.
Review work completed by mentees and provide constructive feedback.
Conduct knowledge-sharing sessions and scientific discussions.
Complete all mandatory internal and client training programs within required timelines.
Support capability development and team growth initiatives.
Required Qualifications
Education
MBBS (Bachelor of Medicine & Bachelor of Surgery)
OR
MD (Doctor of Medicine)
Experience
5–10+ years of experience in:
Pharmacovigilance
Drug Safety
Medical Review
Aggregate Safety Reporting
Risk Management Planning
Signal Management
Experience working with global pharmaceutical, biotechnology, CRO, or healthcare organizations.
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