Pharmacovigilance (PV) Safety Scientist - Benefit Risk / Aggregate Reporting

Why This Role Matters

The PV Safety Scientist plays a crucial role in ensuring patient safety by supporting benefit–risk evaluation activities and regulatory pharmacovigilance reporting. This position contributes to the preparation of high-quality aggregate safety reports and risk management documentation, ensuring compliance with global regulatory standards.
By maintaining data integrity, performing literature reviews, supporting signal management, and collaborating across teams, the role helps safeguard public health and ensures that client deliverables meet strict regulatory timelines and quality benchmarks.

Job Description

ProPharma is seeking a Pharmacovigilance (PV) Safety Scientist to join its team in Bangalore (Onsite/Hybrid model).
The selected candidate will support the Benefit-Risk group in day-to-day pharmacovigilance operations, focusing on aggregate safety reporting, signal management, and regulatory documentation. The role requires close collaboration with senior PV scientists and management to ensure compliance with ICH, FDA, EMA, and other global pharmacovigilance regulations.

Key Features of the Role

• Position: PV Safety Scientist
• Function: Benefit-Risk / Aggregate Reporting
• Location: Bangalore
• Work Model: Onsite / Hybrid
• Experience Required: 2+ years
• Industry: Pharmacovigilance / Regulatory Consulting

Key Responsibilities

Aggregate Safety Reporting
• Author aggregate reports including PSURs/PBRERs, PADERs, Annual Reports, ACO, and DSUR
• Perform literature searches and validity checks for aggregate reports
• Generate Line Listings (LL) from safety databases
• Extract and validate data (RSI, sales data, prior reports, RMPs, signals)
• Reconcile process trackers related to safety reporting

Risk Management & Signal Activities
• Author and update Risk Management Plans (RMPs)
• Prepare Signal Management Reports
• Support benefit–risk evaluation documentation

Operational & Quality Support
• Provide support for high-priority ad-hoc activities
• Ensure regulatory-compliant and timely client deliverables
• Participate in quality discussions internally and with clients
• Support SOP/WI updates, deviations, and CAPA documentation
• Maintain compliance with global PV regulations (ICH-GCP, FDA, EMA, etc.)

Cross-Functional Collaboration
• Liaise with directors, senior PV scientists, and management teams
• Work effectively in a matrix environment
• Contribute to client-facing communications and reporting metrics

Required Qualifications

Educational Background:
• Bachelor’s or Master’s degree in Pharmacy
• Nursing
• Life Sciences
• Other health-related field

Experience:
• Minimum 2+ years of Pharmacovigilance experience
• Experience in aggregate report authoring and literature screening
• Exposure to signal detection or benefit–risk evaluation
• Participation in quality metrics discussions

Technical & Professional Skills:
• Strong analytical and problem-solving skills
• Excellent medical writing and documentation skills
• Ability to synthesize complex medical data into concise scientific narratives
• Strong knowledge of global PV regulations (ICH-GCP, FDA, EMA)
• Proficiency in MS Office (Word, Excel, PowerPoint) and web-based applications
• High attention to detail and regulatory compliance focus

Soft Skills:
• Strong organizational and time-management skills
• Ability to manage regulatory deadlines
• Team-oriented mindset with professional communication skills
• Adaptability to global, multicultural environments

Company Overview

ProPharma has been supporting biotech, medical device, and pharmaceutical organizations for over 20 years. The company provides end-to-end consulting services across the product lifecycle, including regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology solutions.
ProPharma operates through an advise–build–operate model, helping clients de-risk and accelerate high-profile drug and device programs. The organization fosters a culture of diversity, inclusion, collaboration, and professional growth.

Work Model & Culture

While remote working is supported, employees based near office locations are encouraged to work in a hybrid model to benefit from in-person collaboration. All applications are reviewed by the recruitment team without reliance on AI screening tools.

FAQs

Q1. Is aggregate report authoring experience mandatory?
Yes, experience in authoring or reviewing aggregate safety reports is required.

Q2. Is this role client-facing?
Yes, the role involves client deliverables and quality discussions.

Q3. Is signal management experience required?
Experience in signal management or benefit–risk documentation is preferred.

Q4. Does the role require regulatory knowledge?
Yes, strong understanding of ICH-GCP, FDA, EMA, and global PV regulations is essential.

Q5. Is this a remote role?
The position is based in Bangalore with an onsite/hybrid work model.

Application Tip

• Highlight experience in PSUR/PBRER/DSUR authoring
• Mention literature screening and signal detection exposure
• Include examples of regulatory submissions handled
• Showcase medical writing and data analysis expertise
• Emphasize adherence to global pharmacovigilance regulations