Manager-Pharmacovigilance Full Time NEW

Manager – Pharmacovigilance

Job Summary:

We are seeking an experienced and detail-oriented Pharmacovigilance Manager to lead safety surveillance, aggregate reporting, risk management activities, and clinical trial safety operations. The candidate will be responsible for end-to-end pharmacovigilance processes, signal detection, regulatory compliance, cross-functional coordination, and mentoring team members while ensuring high-quality deliverables within timelines.

Key Responsibilities:

Pharmacovigilance & Safety Surveillance

• Lead scientific, technical, and patient safety input for assigned products, systems, and processes.
• Perform safety surveillance activities including periodic report production and monthly signal detection.
• Deliver scientific and surveillance contributions aligned with organizational and business priorities.
• Independently manage end-to-end PV activities for multiple products and support team development.
• Maintain tracking systems for signals, compliance metrics, safety dates, literature reviews, training records, and meeting minutes.

Aggregate Reporting & Regulatory Support

• Lead or co-lead preparation of aggregate safety reports including:
• PSUR
• PBRER
• PADER
• DSUR
• Addendums
• Summary Bridging Reports
• Risk Management Plan (RMP) updates
• Review safety database outputs, line listings, and summary tabulations.
• Compile and present safety data for regulatory submissions and client reports.
• Provide scientific and strategic input for health authority queries and submissions.
• Support regulator queries with awareness of global and cross-country regulatory impact.

Clinical Trial Safety

• Manage clinical trial pharmacovigilance activities including:
• SAE reconciliation
• SUSAR reporting
• DSUR contributions
• Safety surveillance
• Compliance with ICH-GCP and applicable regulations

Signal Management

• Review literature and safety data for potential signals.
• Author signal evaluation reports, aggregate reviews, and assessments for indeterminate signals.
• Support benefit-risk evaluation and risk minimization strategies.

Quality & Compliance

• Review regulatory documents before submission to ensure quality and accuracy.
• Share quality feedback, track defects, and ensure adherence to TAT and SLA commitments.
• Participate in audits, inspections, and CAPA activities.
• Ensure compliance with SOPs, global regulations, and internal quality standards.

Required Qualifications:

• Master’s in Pharmacy, Life Sciences, or healthcare degree such as BDS, MBBS, Nursing, or equivalent.
• Relevant experience in Pharmacovigilance / Drug Safety / Clinical Safety.

Required Skills & Competencies:

• Strong understanding of global PV regulations: FDA, US, EU, ICH, GCP.
• Expertise in aggregate report writing and signal detection.
• Knowledge of safety databases and literature surveillance tools.
• Strong analytical and decision-making skills.
• Excellent written and verbal communication skills.
• Attention to detail and deadline management.
• Ability to work independently and in cross-functional teams.
• Proficiency in MS Office and relevant safety systems.
• Strong interpersonal and stakeholder management skills.

Preferred Experience:

• Experience handling post-marketing and clinical trial safety activities.
• Experience in mentoring teams or leading deliverables.
• Exposure to audits, inspections, and regulatory interactions.