Pharmacovigilance Senior Manager – Global Safety & Benefit-Risk Management
Mumbai, Maharashtra, India (Hybrid Role – 3 Days Office / 2 Days Work From Home)
Company: Pharmanovia
Job Location: Mumbai, Maharashtra, India
Employment Type: Full-Time
Work Model: Hybrid
Experience Required: 12+ Years in Pharmacovigilance & Drug Safety
Industry: Pharmaceuticals | Pharmacovigilance | Drug Safety | Regulatory Affairs
About Pharmanovia
Pharmanovia is a rapidly growing international pharmaceutical company dedicated to improving patient outcomes through the revitalisation of trusted niche medicines. With a portfolio of more than 20 established pharmaceutical brands across 160+ global markets, the organisation operates with a strong patient-centric mission and an expanding international workforce representing over 29 nationalities.
The company specialises in therapeutic areas including Cardiovascular, Oncology, Endocrinology, and Neurology while collaborating with leading pharmaceutical partners to maximise product lifecycle value worldwide.
Job Overview
Pharmanovia is hiring an experienced and strategic Senior Manager – Pharmacovigilance for its Mumbai-based hybrid operations. This senior leadership role is ideal for professionals with extensive expertise in global drug safety, aggregate reporting, benefit-risk evaluation, signal detection, regulatory compliance, and pharmacovigilance system management.
The selected candidate will play a critical role in overseeing global pharmacovigilance activities, ensuring regulatory compliance across international markets, maintaining inspection readiness, and driving proactive patient safety strategies throughout the product lifecycle.
This opportunity is highly suitable for senior pharmacovigilance professionals seeking leadership exposure in a globally expanding pharmaceutical organisation.
Key Responsibilities
Benefit-Risk Evaluation & Aggregate Reporting
Lead global benefit-risk evaluation activities across the product portfolio
Prepare, review, and oversee:
PSURs (Periodic Safety Update Reports)
PBRERs (Periodic Benefit-Risk Evaluation Reports)
RMPs (Risk Management Plans)
Signal detection documentation and safety outputs
Ensure scientifically robust safety evaluations aligned with global regulatory standards
Signal Detection & Risk Management
Drive signal detection, validation, prioritisation, and evaluation processes
Lead risk management activities to maintain favourable product safety profiles
Support implementation of risk minimisation measures across global markets
Pharmacovigilance System & Compliance
Author, maintain, and update the Pharmacovigilance System Master File (PSMF)
Ensure continuous inspection and audit readiness
Monitor pharmacovigilance compliance activities globally
Implement CAPA (Corrective and Preventive Actions) strategies effectively
Vendor & Third-Party Oversight
Establish pharmacovigilance vendor governance frameworks
Manage onboarding, compliance monitoring, performance evaluation, and oversight of PV service providers
Ensure quality standards across outsourced pharmacovigilance operations
Regulatory & Inspection Management
Lead and support health authority inspections and pharmacovigilance audits
Respond to regulatory authority safety queries and compliance requests
Maintain aggregate reporting schedules, including EURD list management
Ensure timely global safety submissions in compliance with EU-GVP, FDA, and local regulations
Cross-Functional Collaboration
Collaborate with Regulatory Affairs, Medical Affairs, Quality Assurance, and senior leadership teams
Support safety labelling updates based on emerging safety signals and regulatory requirements
Contribute to due diligence assessments, product lifecycle decisions, and strategic safety planning
Present pharmacovigilance KPIs and performance metrics to leadership stakeholders
Required Qualifications
Master’s Degree in Pharmacy OR Bachelor’s Degree in Medicine OR equivalent life sciences qualification
Minimum 12+ years of pharmacovigilance experience
Strong expertise in:
Aggregate reporting
Benefit-risk assessment
Signal detection and risk management
Global safety compliance
Proven experience authoring and reviewing:
PSURs
PBRERs
RMPs
Safety evaluation documents
Hands-on experience with:
PSMF management
PV audits and inspections
CAPA management
Vendor oversight
Strong understanding of:
EU-GVP guidelines
FDA pharmacovigilance regulations
Global drug safety requirements
Required Skills
Strong analytical and scientific evaluation capabilities
Excellent stakeholder management and communication skills
Advanced problem-solving and strategic decision-making abilities
High attention to detail and regulatory accuracy
Ability to lead cross-functional global teams
Strong organisational and project management skills
Adaptability in fast-paced global pharmaceutical environments
Why Join Pharmanovia?
Opportunity to shape global pharmacovigilance and patient safety strategies
Senior leadership exposure within an international pharmaceutical company
High-impact role with strong cross-functional visibility
Collaborative and innovation-driven work culture
Exposure to global regulatory and safety operations
Hybrid working flexibility with competitive compensation and employee benefits
Compensation & Benefits
Pharmanovia offers an attractive compensation package including:
Competitive salary structure
Performance-based bonus
Hybrid work model
Paid holidays and leave benefits
Employee recognition programs
Pension scheme
Team engagement and social initiatives
Career growth opportunities within global operations
Equal Opportunity Employer
Pharmanovia is committed to building an inclusive and diverse workplace. The company provides equal employment opportunities to all employees and applicants without discrimination based on race, religion, gender, age, disability, sexual orientation, national origin, marital status, or any legally protected characteristic in accordance with applicable employment laws.
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