Fidelity Health Services Hiring For Drug Safety Executive
Position Name: Drug Safety Executive
Organization: Fidelity Health Services
Qualification: B.Pharm / M.Pharm
Experience: 1-2 Years
Salary: ₹3,00,000 - ₹5,00,000 Per Annum
Location: Ahmedabad, Gujarat, India
Email: hrrecruitment@fidelityhs.com
Responsibilities
- Perform duplicate check and book‑in of adverse event reports in Oracle Argus safety database
- Conduct case intake and initial data verification against source documents
- Enter individual case safety report (ICSR) data accurately into Argus
- Review and validate completeness and correctness of case information
- Perform data quality review and resolve discrepancies
- Conduct date correction of ICSR entries identified during signal detection
- Generate and maintain action items for follow‑up investigations
- Process scientific literature cases, including extraction of safety data
- Conduct literature search and evaluate relevance to product safety
- Prepare and submit safety signals and health hazard assessment reports
- Contribute to routine signal review and trend analysis activities
- Perform post‑process quality check (PPQC) on completed cases
- Review FDA Adverse Event Reporting System (FAERS) data for relevant cases
- Liaise with cross‑functional teams to obtain missing information
- Draft safety narratives and case summaries for regulatory submissions
- Ensure compliance with internal SOPs and global pharmacovigilance regulations
- Participate in periodic audits and implement corrective actions
- Maintain case management timelines as per regulatory requirements
- Update and maintain case tracking logs and dashboards
- Provide safety information to investigators and health authorities when required
- Support preparation of periodic safety update (PSUR) data extracts
- Assist in the preparation of risk management plans (RMP) related data
- Contribute to training of junior safety associates on Argus usage
- Monitor and respond to safety queries from internal stakeholders
- Document all case activities in accordance with GVP guidelines
- Perform root‑cause analysis for recurring data quality issues
- Support the implementation of new safety database functionalities
- Participate in cross‑functional safety meetings and project teams
- Ensure proper archiving of case files and supporting documents
- Generate ad‑hoc safety reports for senior management
Skills
- Oracle Argus Safety database proficiency
- Case processing and duplicate detection
- ICSR data entry accuracy
- Knowledge of Good Pharmacovigilance Practices (GVP)
- Understanding of ICH E2B(R3) standards
- Familiarity with FDA FAERS reporting
- Scientific literature review techniques
- Signal detection and assessment
- Health hazard assessment (HHA) methodology
- Post‑process quality check (PPQC) execution
- Strong attention to detail
- Analytical thinking and problem solving
- Excellent written communication
- Ability to draft safety narratives
- Time‑management and case prioritization
- Knowledge of regulatory requirements (US, EU, WHO)
- Proficiency in Microsoft Office (Excel, Word, PowerPoint)
- Data reconciliation and discrepancy resolution
- Ability to work under tight deadlines
- Team collaboration and cross‑functional liaison
- Understanding of pharmacology and drug safety concepts
- Experience with literature database tools (PubMed, Embase)
- Risk management plan (RMP) data handling
- Ability to conduct root‑cause analysis
- Knowledge of SOP development and compliance
- Basic statistical analysis for signal evaluation
- Adaptability to evolving safety regulations
- Strong organizational skills
- Ability to maintain confidentiality of patient data
- Continuous learning mindset for emerging safety trends
Company Overview
Fidelity Health Services is a leading integrated healthcare solutions provider headquartered in Ahmedabad, Gujarat, with a strong focus on pharmacovigilance, drug safety, and regulatory affairs. The company offers end‑to‑end safety monitoring services for multinational pharmaceutical manufacturers, biotech firms, and medical device companies. With a robust portfolio that includes adverse event management, signal detection, risk management planning, and post‑marketing surveillance, Fidelity Health Services has earned a reputation for scientific excellence and regulatory compliance across US, EU, and emerging markets. Employees benefit from a collaborative culture that encourages continuous learning, access to state‑of‑the‑art safety databases, and opportunities for career advancement into senior pharmacovigilance and global safety leadership roles. The organization’s commitment to innovation, data integrity, and patient safety makes it an attractive destination for aspiring drug safety professionals seeking to grow in a dynamic, high‑impact environment.
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Common Interview Questions for Drug Safety Executive
Prepare for your interview by reviewing these frequently asked questions. Click on a question to reveal the answer.
What are the key steps you follow when performing a duplicate check in Oracle Argus?
First, I run the built‑in duplicate detection algorithm using the case’s primary identifiers (patient ID, event date, drug name, and MedDRA term). I then manually review flagged records, compare source documents, and verify that the duplicate is not a true separate case. If a duplicate is confirmed, I merge the cases according to SOP, ensuring that all unique data elements are retained and audit trails are updated.
How do you ensure data quality during case entry in the safety database?
I follow a three‑layered approach: (1) cross‑check each data element against the source document, (2) use validation rules in Argus to catch format or range errors, and (3) perform a secondary review by a peer or senior associate before case closure. Any discrepancy is documented, investigated, and resolved according to the data‑quality SOP.
Explain the difference between an Individual Case Safety Report (ICSR) and a literature case.
An ICSR originates from a spontaneous report, clinical trial, or post‑marketing source and contains patient‑specific information captured directly from the reporter. A literature case is extracted from published scientific articles, conference abstracts, or regulatory documents; it requires careful interpretation of the published data to map it to the ICSR structure, often with limited patient details.
What is the purpose of a Health Hazard Assessment (HHA) and how do you contribute to it?
An HHA evaluates the potential impact of a safety signal on public health, considering severity, frequency, and causality. I contribute by providing accurate case data, performing signal validation, and preparing concise summaries that highlight the clinical relevance, which are then used by the safety assessment team to determine risk mitigation actions.
Describe how you would handle a case that requires date correction after signal review.
I locate the original case in Argus, verify the correct date from the source document, and use the ‘Date Correction’ function to amend the event date. I document the reason for the change, update the audit trail, and notify the signal review team to ensure the corrected date is reflected in any ongoing analyses.
What are the essential elements of a safety narrative?
A safety narrative includes patient demographics, medical history, drug exposure details, description of the adverse event, chronology of events, outcome, and assessment of causality. It must be concise, factual, and written in a clear, chronological format that aligns with regulatory guidance.
How do you stay updated with changes in global pharmacovigilance regulations?
I subscribe to regulatory newsletters from FDA, EMA, and WHO, attend quarterly webinars hosted by industry associations, review updates on ICH guidelines, and participate in internal training sessions. I also maintain a personal log of regulatory changes and share relevant updates with the team during weekly meetings.
Can you explain the process of preparing a Periodic Safety Update Report (PSUR) data extract?
I retrieve all relevant cases for the reporting period using Argus queries, ensure data completeness, perform quality checks, and export the dataset in the required format (e.g., Excel or XML). I then reconcile the extract with the PSUR template, verify that all signal and aggregate data are accurately represented, and coordinate with the medical writing team for final review.
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