Safety Specialist II
Location: India
Work Mode: Not Specified (Likely On-site or Hybrid)
Job Summary
We are looking for a detail-oriented and experienced Safety Specialist II to join our pharmacovigilance (PV) team. The successful candidate will play a crucial role in authoring and reviewing aggregate safety reports, managing signal detection and risk management plans, and supporting various PV-related activities. This is a great opportunity for professionals with a passion for drug safety and regulatory compliance to work in a dynamic and global environment.
Key Responsibilities
Aggregate Reports
Author and review DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports.
Generate line listings (LL) and summary tabulations (ST) from the safety database.
Analyze safety and regulatory data to prepare complete Aggregate Reports.
Perform literature screening to include significant safety articles in reports.
Compile benefit-risk evaluation sections from medical reviewers.
Address internal and external reviewer comments and finalize reports.
Participate in internal and external audits and inspections.
Signal Management and Risk Management Plans
Conduct signal detection, validation, assessment, and benefit-risk analysis.
Use appropriate signal detection tools for screening and data mining.
Generate LL and ST from Argus/client safety databases.
Draft and monitor Risk Management Plans per SOPs.
Track signals and monitor their lifecycle status (potential, open, refuted, validated).
Required Skills & Qualifications
Strong experience in Aggregate Safety Reports authoring and review.
Expertise in PBRER Aggregate Reports.
Ability to support Individual Case Safety Report (ICSR) teams.
Knowledge of GCP, GVP, ICH, USFDA guidelines and PV regulations.
Familiarity with pharmacovigilance and medical terminologies.
Competence in MS Office Suite (Word, Excel, PowerPoint).
Excellent written and spoken English; knowledge of additional languages is a plus.
Strong communication, organizational, and teamwork skills.
Perks & Benefits
Opportunity to work in a globally recognized PV organization.
Exposure to diverse global pharmacovigilance and drug safety projects.
Structured career path with professional growth potential.
Involvement in regulatory inspections and audits.
Competitive salary package (Not specified).
Company Description
Join a global leader in pharmacovigilance and drug safety services, committed to ensuring the safe use of pharmaceutical products. The company offers comprehensive PV solutions, risk management, and regulatory compliance support to leading pharma organizations worldwide.
Work Mode
Not specified (Assumed On-site or Hybrid).
Call-to-Action
Are you ready to enhance patient safety and advance your career in pharmacovigilance? Apply now to become a Safety Specialist II and make a meaningful impact in global drug safety.
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