Safety Specialist II – Pharmacovigilance & Aggregate Reporting
Location: [Not Specified]
Experience: 2–5 years
Job Type: Full-Time
Job Overview:
We are hiring a Safety Specialist II to support our expanding pharmacovigilance team. This position plays a key role in authoring aggregate safety reports, signal management, and risk management plan development. The ideal candidate should possess strong analytical abilities, a deep understanding of global PV regulations, and experience with safety databases and aggregate reporting formats such as PBRER, DSUR, PSUR, PADER, and Canadian Reports.
Key Responsibilities:
Aggregate Reports:
Author and review aggregate safety documents: DSURs, PBRERs, PSURs, PADERs, Canadian Reports, and others per project requirements.
Extract and review safety data to generate line listings (LL) and summary tabulations (ST), incorporating them into standardized templates.
Analyze client-provided safety and regulatory data to draft comprehensive reports.
Conduct literature screening to include significant safety-related findings in the relevant sections.
Collaborate with medical reviewers to compile benefit-risk evaluation sections.
Address reviewer comments and finalize reports within agreed timelines.
Participate in internal and external audits and regulatory inspections.
Signal Management & Risk Plans:
Conduct data mining, frequency tabulations, and screening for potential safety signals using appropriate tools and databases (e.g., Argus).
Perform signal validation, assessment, benefit-risk analysis, and prioritization per regulatory guidelines.
Monitor and track signal statuses: open, validated, refuted, or potential.
Assist in the creation and maintenance of Risk Management Plans in compliance with client or internal SOPs.
Ensure adherence to applicable SOPs, conventions, and regulatory guidelines.
Desirable Skills and Experience:
Demonstrated experience in authoring PBRERs and other aggregate safety reports.
Ability to assist cross-functional teams including ICSR and Literature Review units based on workload.
Familiarity with scheduling/report tracking tools for pharmacovigilance activities.
Strong understanding of medical and PV terminology, GCP, GVP, ICH, USFDA, and global PV regulations.
Hands-on experience with PV safety databases (e.g., Argus) and tools for signal detection.
Excellent command of written and spoken English; knowledge of additional languages is a plus.
Proficiency in MS Office (Word, Excel, PowerPoint).
Strong organizational, communication, problem-solving, and teamwork skills.
Estimated Salary: ₹6 – ₹10 LPA (based on experience and responsibilities)
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