Location: India (Remote / Hybrid – Preference for Hyderabad-based candidates)
Company: ProPharma Group
Job ID: JR 9433
Job Type: Full-Time
Experience Required: Freshers or Minimum 2+ years (suitable for freshers)
About the Company
ProPharma Group is a leading global provider of regulatory, clinical, and pharmacovigilance solutions, supporting biotech, pharmaceutical, and medical device organizations across the entire product lifecycle. With over two decades of industry impact, the company delivers end-to-end consulting services that accelerate drug development, ensure compliance, and enhance patient safety worldwide.
Job Overview
We are hiring a Pharmacovigilance Scientist to join the Benefit-Risk team, focusing on aggregate safety reporting, signal management, and regulatory compliance. This role is critical for ensuring the scientific accuracy, quality, and timely delivery of pharmacovigilance outputs in alignment with global regulatory standards.
You will collaborate with senior safety scientists, medical reviewers, and cross-functional stakeholders to support high-impact drug safety activities across global markets.
Key Responsibilities
Author and review aggregate safety reports including PSURs, PBRERs, PADERs, DSURs, and Annual Reports
Prepare, update, and maintain Risk Management Plans (RMPs)
Contribute to signal detection, signal evaluation, and signal management reports
Perform literature searches, screening, duplicate checks, and case validity assessments
Extract, validate, and analyze safety data from multiple sources including RSI, sales data, and prior reports
Generate and review line listings (LLs) using pharmacovigilance safety databases
Maintain trackers, ensure reconciliation, and support compliance documentation
Assist in handling high-priority pharmacovigilance deliverables and ad hoc requests
Ensure adherence to global pharmacovigilance regulations, timelines, and quality standards
Participate in audits, inspections, and quality reviews as a Subject Matter Expert (SME)
Support SOP development, deviations handling, and CAPA implementation
Skills and Competencies
Strong analytical thinking with problem-solving capabilities
High attention to detail and commitment to quality
Excellent time management and organizational skills
Ability to work in a global, matrix-driven environment
Strong medical writing and scientific communication skills
Ability to interpret complex clinical and safety data effectively
Good understanding of global pharmacovigilance regulations including ICH-GCP, FDA, and EMA guidelines
Proficiency in MS Office tools and pharmacovigilance systems
Educational Requirements
Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences, or a related healthcare discipline
Equivalent industry experience may also be considered
Experience Requirements
Minimum 2+ years of hands-on experience in Pharmacovigilance
Experience in aggregate report writing (PSUR, PBRER, DSUR, etc.)
Exposure to signal detection and literature review processes
Prior experience in medical writing and safety data analysis is highly preferred
Experience in client-facing projects and quality metrics is an added advantage
Work Model and Location Flexibility
This is primarily a remote role across India. However, candidates located in or near Hyderabad may be required to attend office-based collaboration sessions periodically, based on project needs.
Diversity, Equity, and Inclusion
ProPharma Group fosters an inclusive work culture where innovation, collaboration, and individuality are valued. The organization is committed to providing equal opportunities and creating a safe, empowering workplace for all employees.
Important Application Information
All applications are reviewed manually by the recruitment team
No AI-based screening tools are used in the hiring process
Applicants will receive a response regarding their application status
ProPharma does not request any payment or financial details during recruitment
Only official email communications from the company domain should be considered valid
Important Note for Freshers
This position requires prior pharmacovigilance experience. Freshers are encouraged to apply for entry-level roles such as Drug Safety Associate, PV Case Processor, or Medical Writer positions to begin their career in pharmacovigilance.
How to Apply
Apply through the official careers page or explore verified global pharmacovigilance opportunities on ThePharmaDaily.com to accelerate your career in drug safety and clinical research.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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