Experience: 3–6 Years (Preferred)
Qualification: B.Pharm / M.Pharm / Pharm.D / Life Sciences
Job Overview
We are looking for a detail-oriented Aggregate Report Writer to join our Pharmacovigilance team. The ideal candidate will be responsible for preparing and reviewing aggregate safety reports, risk management plans, and signal management reports in compliance with global regulatory requirements.
The role involves collaborating with cross-functional teams to ensure timely submission of high-quality safety documents to health authorities while maintaining compliance with pharmacovigilance guidelines and industry standards.
Key Responsibilities
Aggregate Report Writing
- Author and review Aggregate Safety Reports including PSURs, PBRERs, PADERs, Annual Reports, DSURs, and ACO reports for submission to global and local health authorities.
- Ensure reports comply with regulatory guidelines and submission timelines.
- Prepare high-quality safety documents with accurate scientific and medical content.
Risk Management & Signal Management
- Develop and maintain Risk Management Plans (RMPs) as part of routine pharmacovigilance activities.
- Prepare and review Signal Management Reports.
- Support benefit-risk evaluation and safety monitoring activities.
Data Collection & Validation
- Perform literature searches and validity assessments for aggregate reports.
- Extract, validate, and reconcile safety data from multiple sources including RSI, sales data, previous reports, RMPs, and safety signals.
- Generate and validate Line Listings (LL) from safety databases.
Compliance & Documentation
- Maintain process trackers and ensure accurate documentation.
- Support regulatory submissions by providing complete and compliant safety documentation.
- Ensure adherence to global pharmacovigilance regulations, SOPs, and company quality standards.
Cross-Functional Collaboration
- Work closely with Pharmacovigilance, Regulatory Affairs, Medical Writing, and Safety teams.
- Provide support for high-priority and ad-hoc pharmacovigilance activities.
- Ensure timely completion of assigned projects while maintaining data quality and compliance.
Required Qualifications
- B.Pharm / M.Pharm / Pharm.D / Life Sciences or equivalent qualification.
- Experience in Pharmacovigilance Aggregate Report Writing preferred.
- Strong understanding of global pharmacovigilance regulations and safety reporting requirements.
Required Skills
- Aggregate Report Writing
- PSUR
- PBRER
- PADER
- DSUR
- Annual Safety Reports
- Risk Management Plans (RMP)
- Signal Management
- Pharmacovigilance
- Medical Writing
- Literature Review
- Safety Database Management
- Line Listing Generation
- Regulatory Documentation
- Data Validation
- Regulatory Compliance
- Time Management
- Attention to Detail
Preferred Skills
- Experience with global pharmacovigilance guidelines (ICH, EMA, FDA).
- Knowledge of safety databases such as Argus or ARISg.
- Excellent scientific writing and documentation skills.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple reports and meet strict regulatory timelines.
Why Join Us?
- Opportunity to work on global pharmacovigilance projects.
- Exposure to international regulatory submissions and safety reporting.
- Collaborative work environment with experienced life sciences professionals.
- Excellent career growth opportunities in Pharmacovigilance and Regulatory Affairs.
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