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Safety Specialist Ii

2-5 years
₹6 – ₹10 LPA
10 July 22, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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)