Safety Specialist II – Pharmacovigilance
Job Summary:
Join a global leader in life sciences as a Safety Specialist II, contributing to key pharmacovigilance activities including Aggregate Safety Reports, Signal Management, and Risk Management Plans. This role is ideal for professionals with a strong background in safety report authoring and regulatory compliance. Work closely with medical reviewers, PV teams, and regulatory bodies to ensure patient safety and data integrity.
Key Responsibilities:
Author and review Aggregate Safety Reports (DSURs, PBRERs, PSURs, PADERs, Canadian Aggregate Reports).
Perform literature screening and incorporate significant safety articles.
Prepare line listings (LL) and summary tabulations (ST) from safety databases such as Argus.
Analyze safety and regulatory data to meet client-specific requirements.
Address comments from internal and external reviewers and finalize reports.
Participate in audits and inspections by clients and regulatory authorities.
Conduct Signal Management activities including data mining, tabulation, and signal detection.
Draft signal validation, assessment, and benefit-risk evaluations.
Monitor and track signal statuses as per regulatory and internal processes.
Develop and maintain Risk Management Plans and ensure SOP compliance.
Support Individual Case Safety Report (ICSR) and Literature Review teams as required.
Required Skills & Qualifications:
3+ years’ experience in pharmacovigilance and aggregate report authoring.
Proficiency in PBRERs, DSURs, PSURs, and signal management tools.
Familiarity with Argus safety database or equivalent.
Strong understanding of GCP, GVP, ICH, USFDA guidelines.
Medical and therapeutic terminology knowledge.
Excellent written and verbal English communication; additional languages are a plus.
Proficient in MS Office (Word, Excel, PowerPoint).
Strong organizational, teamwork, and time management skills.
Perks & Benefits:
Work on global PV projects with leading pharma clients.
Opportunities for career growth in risk management and signal detection.
Access to continuous training and development programs.
Collaborative, inclusive, and knowledge-sharing work environment.
Company Description:
Navitas Life Sciences is a trusted global provider of pharmacovigilance, regulatory affairs, and clinical development services. With expertise across multiple therapy areas, we deliver reliable, innovative solutions to top pharma and healthcare companies worldwide.
Work Mode:
Hybrid / On-site (Location not specified)
Call to Action:
Ready to enhance patient safety and pharmacovigilance operations? Apply now for the Safety Specialist II position and be part of an industry-leading team shaping global drug safety practices.
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