Safety Specialist II – Navitas Life Sciences
Location: Bangalore, India
Department: Regulatory Affairs / Pharmacovigilance
Employment Type: Full-Time
Experience Level: Analyst
Job Purpose
The Safety Specialist II is responsible for the preparation, review, and analysis of aggregate safety reports, signal management, and risk management activities, ensuring compliance with regulatory requirements and client expectations.
Key Responsibilities
Aggregate Reports
Author and review aggregate safety reports, including:
DSURs (Development Safety Update Reports)
PBRERs (Periodic Benefit-Risk Evaluation Reports)
PSURs (Periodic Safety Update Reports)
PADERs (Periodic Adverse Drug Experience Reports)
Canadian Aggregate Reports
Review safety data from databases and generate line listings (LL) and summary tabulations (ST), including these in appropriate report templates.
Analyze safety and regulatory data provided by clients and prepare complete aggregate reports as per client requirements.
Perform literature screening to include significant safety articles in the respective sections of reports.
Compile benefit-risk evaluation sections provided by medical reviewers, where applicable.
Ensure compliance with internal and external timelines.
Address comments from internal and external/client reviewers and finalize reports.
Participate in internal and external audits and inspections by clients and health authorities.
Signal Management & Risk Management Plans
Screen, mine data, and tabulate frequencies for potential signals; perform signal estimation using appropriate detection tools per client requirements.
Generate line listings and summary tabulations from Argus or client safety databases.
Draft signal detection, validation, assessment, and benefit-risk analysis, prioritizing signals based on available data.
Ensure compliance with relevant SOPs, conventions, and guidelines for all signal-related activities.
Track identified signals from regulatory and internal processes, monitoring status as potential, open, refuted, or validated signals.
Develop Risk Management Plans and related activities according to Navitas Life Sciences/client SOPs.
Desirable Skills & Experience
Experience authoring and reviewing Aggregate Safety Reports (PBRERs preferred).
Ability to support Individual Case Safety Report (ICSR) and literature review teams.
Assist in report scheduling and workload management.
Strong understanding of medical and pharmacovigilance terminologies.
Knowledge of GCP, GVP, ICH, US FDA guidelines, and other relevant pharmacovigilance regulations.
Familiarity with patient safety regulatory obligations.
Competence in medical and therapeutic terminology.
Strong command of written and spoken English; additional languages are a plus.
Proficiency in MS Office (Word, Excel, PowerPoint).
Soft skills: motivation, structured work approach, organization, reliability, teamwork, and strong communication.
Educational Qualifications
Graduate or postgraduate degree in:
Life Sciences
Pharmacy
Medicine
Dentistry
Allied Health Sciences
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