Location: India (Remote | Preference: Hyderabad – Hybrid Collaboration)
Company: ProPharma
Job ID: JR 9433
Employment Type: Full-Time
Experience Required: Minimum 2+ years (Not suitable for freshers)
About the Company
ProPharma is a globally trusted partner in regulatory sciences, clinical research, pharmacovigilance, and medical information services. With over two decades of industry impact, the organization supports biotech, pharmaceutical, and medical device companies in accelerating product development and ensuring compliance across the entire product lifecycle.
Job Overview
This opportunity is ideal for professionals looking to advance their career in pharmacovigilance, particularly in benefit-risk evaluation and aggregate safety reporting. As a Pharmacovigilance Scientist, you will contribute to critical drug safety deliverables, ensuring regulatory compliance and high-quality scientific outputs.
You will collaborate with global stakeholders, senior safety scientists, and cross-functional teams to support safety surveillance, signal detection, and risk management activities.
Key Responsibilities
Author and review aggregate safety reports including PSURs, PBRERs, PADERs, DSURs, and Annual Reports
Develop and maintain Risk Management Plans (RMPs) in line with global regulatory expectations
Contribute to signal detection and signal management reports
Conduct literature searches, screening, duplicate checks, and validity assessments
Extract, analyze, and validate safety data including RSI, sales data, and prior safety reports
Generate and review line listings from pharmacovigilance databases
Maintain trackers, reconciliation activities, and documentation processes
Support urgent and ad hoc pharmacovigilance deliverables
Ensure compliance with global regulatory authorities including ICH, FDA, and EMA guidelines
Participate in audits and inspections as a Subject Matter Expert when required
Contribute to SOPs, Work Instructions, deviations, and CAPA processes
Required Skills and Competencies
Strong expertise in pharmacovigilance and aggregate safety reporting
Excellent analytical thinking and problem-solving capabilities
High attention to detail with a strong quality mindset
Effective time management and organizational skills
Strong medical writing and scientific communication abilities
Ability to interpret and summarize complex clinical and safety data
Experience working in global, cross-functional environments
Proficiency in MS Office tools and pharmacovigilance systems
Educational Qualifications
Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences, or related healthcare discipline
Equivalent relevant experience may be considered
Experience Requirements
Minimum 2+ years of experience in Pharmacovigilance
Hands-on experience in one or more of the following areas:
Aggregate report writing
Literature screening and review
Signal detection and safety data analysis
Experience in authoring or reviewing aggregate safety reports is essential
Exposure to quality metrics and client interactions is an added advantage
Work Model
Remote-first role across India
Candidates based near Hyderabad are preferred for periodic hybrid collaboration
Why Apply for This Role
Opportunity to work on global pharmacovigilance projects with high regulatory impact
Exposure to end-to-end drug safety lifecycle and benefit-risk management
Collaborative environment with industry-leading experts
Strong career growth in drug safety, aggregate reporting, and regulatory strategy
Important Note for Applicants
This position requires prior pharmacovigilance experience. Freshers are advised to apply for entry-level roles such as Drug Safety Associate, PV Case Processor, or Medical Writer positions to build foundational experience before transitioning into scientist-level roles.
Application Process
All applications are reviewed directly by the recruitment team at ProPharma. Candidates will receive communication regarding their application status.
Applicants are advised to apply only through official company channels. No payment or financial information is required during the hiring process.
Explore More Opportunities
For verified global pharmacovigilance and clinical research jobs, visit ThePharmaDaily.com and stay updated with the latest hiring trends in the life sciences industry.
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