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Direct real-time notification feeds for verified Pharmaceutical, Clinical SAS, CDM, and Pharmacovigilance careers:
Qinecsa Solutions Hiring for Drug Safety Associate I in Bengaluru
Position Overview & Specifications
| Parameter | Official Specifications |
|---|---|
| Hiring Organization | Qinecsa Solutions |
| Designation / Track | Drug Safety Associate I (Pharmacovigilance Operations) |
| Target Qualifications | B.Pharm, M.Pharm, Pharm.D, BDS, MBBS, Life Sciences |
| Experience Profile | 1 to 3 Years ICSR Processing Experience |
| Core Competencies | Argus Safety, MedDRA / WHO-DD Coding, Causality Assessment |
| Work Location | Bengaluru, Karnataka |
| Application Mode | Direct Official Online Application |
Verified Vacancy Matrix & Hiring Tracks
Review all active hiring tracks below. Direct official application links for each position are provided at the bottom of this notification:
| # | Designation & Hiring Track | Work Location | Experience & Mode |
|---|---|---|---|
| 1 |
#1Drug Safety Associate I (PV Operations)
Pharmacovigilance (PV) |
Location: Bengaluru
|
Experience: 1 – 3 Yrs Online Portal
|
Key Roles & Detailed Responsibilities
- Execute end-to-end clinical data operations, trial documentation, or statistical programming workflows strictly aligned with Qinecsa Solutions’s Standard Operating Procedures (SOPs).
- Ensure 100% adherence to global regulatory frameworks including ICH-GCP guidelines, USFDA 21 CFR Part 11, and CDISC SDTM/ADaM submission standards.
- Perform technical quality reviews, trial master file (TMF) audits, safety event reconciliation, and clinical database validation deliverables.
- Collaborate cross-functionally with biostatisticians, clinical data managers, medical writers, and enterprise safety review boards.
Eligibility Criteria & Candidate Profile
- Academic Qualifications: Candidates must possess B.Pharm, M.Pharm, Pharm.D, BDS, MBBS, Life Sciences from an accredited university or approved technical institution.
- Experience Profile: 1 – 3 Years Experience with demonstrated hands-on technical proficiency in target operational workflows.
- Regulatory & Quality Knowledge: Solid foundational awareness of pharmaceutical compliance (cGMP, ICH-GCP, GLP, 21 CFR Part 11, or CDSCO standards).
- Core Competencies: Excellent analytical problem-solving skills, rigorous documentation hygiene, and strong verbal/written technical communication.
Core Technical Competencies & Instruments Matrix
Candidates possessing hands-on proficiency across the following analytical tools, software systems, and regulatory standards will receive priority evaluation:
Argus Safety & ArisG Global Drug Safety DatabasesICSR Case Processing & Triaging (Initial, Follow-Up & Spontaneous)MedDRA Hierarchy Coding (LLT, PT, HLT, HLGT, SOC) & WHO-DDMedical Case Narrative Writing & Clinical Causality AssessmentExpedited Reporting Timelines (7-Day Fatal & 15-Day Serious Events)Electronic Data Transmission Standards (E2B R2 and E2B R3 XML)Aggregate Safety Reports (PSUR / PBRER / DSUR Authoring)Signal Detection, Safety Surveillance & Risk Management Plans (RMP)Scientific Literature Screening & Global Health Authority QueriesUSFDA FAERS, EMA EudraVigilance & MHRA Yellow Card Governance
Daily Operational Workflow & Core Shift Duties
Detailed technical breakdown of standard shift activities, laboratory/plant floor execution, and daily operational deliverables for Drug Safety Associate I (Pharmacovigilance):
Duty 1ICSR Intake, Triaging & Registration
Receiving spontaneous, clinical, and literature adverse event cases; verifying minimum criteria (patient, reporter, drug, event) in Argus Safety.
Duty 2Medical Terminology & Drug Coding
Coding reported adverse events using MedDRA hierarchy (LLT to SOC) and suspect medicinal products using the WHO Drug Dictionary.
Duty 3Clinical Case Narrative Writing
Composing comprehensive chronological medical narratives documenting patient history, drug start/stop dates, event progression, and dechallenge/rechallenge.
Duty 4Causality & Seriousness Assessment
Evaluating medical plausibility, WHO-UMC causality classification, and seriousness criteria (death, hospitalization, disability).
Duty 5Expedited Regulatory Submission
Generating E2B(R3) XML transmission files and submitting reports to health authorities within 7-day or 15-day statutory regulatory clocks.
Regulatory & Quality Compliance Framework
Candidates must demonstrate operational awareness and rigorous adherence to the following regulatory chapters and international standards governing this role:
ICH E2A & E2B (R3)
Safety Data & Electronic Transmission
Establishes definitions of adverse drug reactions, expedited reporting thresholds, and XML schema standards for ICSR interchange.
EMA GVP Modules I-XVI
European Good Pharmacovigilance Practices
Binding European standards governing quality systems, pharmacovigilance system master file (PSMF), periodic safety reports, and signal detection.
USFDA 21 CFR 314.80 & 312.32
Postmarketing & IND Safety Reporting
Mandatory federal timelines for reporting unexpected serious adverse drug experiences in marketed drugs and clinical studies.
ICH E2C (R2) / PBRER Guidelines
Periodic Benefit-Risk Reporting
Comprehensive format and content guidelines for presenting cumulative worldwide safety experience during a product lifecycle.
Tailored Resume Guidelines for Drug Safety Associate I (Pharmacovigilance)
- Highlight Core Technical Instrumentation & Software: Explicitly mention hands-on software platforms (Empower 3, SAS, Argus, EDC Rave) or laboratory equipment relevant to Drug Safety Associate I (Pharmacovigilance) at the top of your resume.
- Quantify Accomplishments & Throughput: Instead of passive duty descriptions, quantify measurable deliverables (e.g., ‘Validated 15+ analytical methods per ICH Q2’, ‘Processed 120+ clinical safety ICSRs per month’, ‘Supervised 50+ commercial batches with zero deviations’).
- Standardize on ATS-Friendly Clean Formatting: Use standard single-column reverse-chronological format with clean bullet points. Strictly avoid multi-column layouts, graphics, icons, or text boxes that confuse automated enterprise ATS parsers.
- Calibrate Regulatory Terminology: Integrate exact industry compliance acronyms (e.g., cGMP, ICH-GCP, ALCOA+, 21 CFR Part 11, USFDA audit readiness) naturally throughout your project and experience narratives.
Technical Interview Assessment & Guidance
Q: What are the 4 minimum mandatory criteria required to consider an Individual Case Safety Report (ICSR) valid for regulatory processing?
Authoritative Answer: Under international regulatory standards (ICH E2A), a valid ICSR requires four essential data elements: 1) An Identifiable Patient (patient initials, age, gender, or patient identification number); 2) An Identifiable Reporter (name, address, qualification, or contact information); 3) At least one Suspect Drug/Medicinal Product (brand or generic active substance); and 4) At least one Adverse Event/Reaction (clinical symptom, sign, or pathological outcome). If any of these four elements is missing, the case is invalid and follow-up attempts are made to gather missing details.
Authoritative Answer: Under international regulatory standards (ICH E2A), a valid ICSR requires four essential data elements: 1) An Identifiable Patient (patient initials, age, gender, or patient identification number); 2) An Identifiable Reporter (name, address, qualification, or contact information); 3) At least one Suspect Drug/Medicinal Product (brand or generic active substance); and 4) At least one Adverse Event/Reaction (clinical symptom, sign, or pathological outcome). If any of these four elements is missing, the case is invalid and follow-up attempts are made to gather missing details.
Q: How is seriousness determined for an adverse event, and what are the expedited regulatory reporting deadlines?
Authoritative Answer: An Adverse Event is classified as ‘Serious’ if it satisfies any of the following criteria: Results in Death; Is Life-Threatening; Requires Inpatient Hospitalization or Prolongation of Existing Hospitalization; Results in Persistent or Significant Disability/Incapacity; Is a Congenital Anomaly/Birth Defect; or Is another Medically Significant Event requiring intervention to prevent one of the outcomes above. For serious, unexpected adverse reactions (SUSARs), fatal or life-threatening events must be reported to the regulatory authority within 7 calendar days (with a complete follow-up report within an additional 8 days). All other serious unexpected events must be filed within 15 calendar days.
Authoritative Answer: An Adverse Event is classified as ‘Serious’ if it satisfies any of the following criteria: Results in Death; Is Life-Threatening; Requires Inpatient Hospitalization or Prolongation of Existing Hospitalization; Results in Persistent or Significant Disability/Incapacity; Is a Congenital Anomaly/Birth Defect; or Is another Medically Significant Event requiring intervention to prevent one of the outcomes above. For serious, unexpected adverse reactions (SUSARs), fatal or life-threatening events must be reported to the regulatory authority within 7 calendar days (with a complete follow-up report within an additional 8 days). All other serious unexpected events must be filed within 15 calendar days.
Q: How do you write a clear, audit-compliant medical narrative for a complex ICSR in Argus Safety?
Authoritative Answer: A compliant ICSR medical narrative follows a strict chronological structure: 1) Demographic details (age, sex, medical history, concurrent illnesses); 2) Drug administration timeline (suspect medication name, indication, dose, route, start date, lot number); 3) Event chronology (onset date, time, clinical signs, severity, hospitalization details); 4) Diagnostic workup (laboratory investigations, imaging, biopsy findings); 5) Treatment and Action Taken with suspect drug (dechallenge – drug stopped or reduced, rechallenge if re-administered); 6) Event Outcome (recovered, recovering, fatal, not recovered); and 7) Reporter and Company Causality Assessment with differential diagnosis.
Authoritative Answer: A compliant ICSR medical narrative follows a strict chronological structure: 1) Demographic details (age, sex, medical history, concurrent illnesses); 2) Drug administration timeline (suspect medication name, indication, dose, route, start date, lot number); 3) Event chronology (onset date, time, clinical signs, severity, hospitalization details); 4) Diagnostic workup (laboratory investigations, imaging, biopsy findings); 5) Treatment and Action Taken with suspect drug (dechallenge – drug stopped or reduced, rechallenge if re-administered); 6) Event Outcome (recovered, recovering, fatal, not recovered); and 7) Reporter and Company Causality Assessment with differential diagnosis.
Mandatory Documents Checklist for Interview & Verification
Ensure you organize the following original credentials and self-attested photocopies for technical interviews and HR onboarding verification:
Curriculum Vitae (2 Hard Copies)
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Academic Certificates & Marksheets
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Government Photo Identification
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Past 3 Months Salary Slips & Bank Records
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Relieving & Appointment Letters
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Passport Photographs & Professional Registration
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
Frequently Asked Questions (FAQ)
Q: What is the official application procedure for Drug Safety Associate I (Pharmacovigilance) at Qinecsa Solutions?
Answer: Candidates must review the specified academic qualifications and functional criteria, calibrate their CV, and submit applications directly through Qinecsa Solutions’s official career ATS portal or designated HR application channel provided at the bottom of this notification.
Answer: Candidates must review the specified academic qualifications and functional criteria, calibrate their CV, and submit applications directly through Qinecsa Solutions’s official career ATS portal or designated HR application channel provided at the bottom of this notification.
Q: What academic backgrounds and degrees are eligible for this hiring drive?
Answer: Eligible qualifications include B.Pharm, M.Pharm, Pharm.D, BDS, MBBS, Life Sciences. Both entry-level and experienced professionals matching the functional tracks are eligible to apply.
Answer: Eligible qualifications include B.Pharm, M.Pharm, Pharm.D, BDS, MBBS, Life Sciences. Both entry-level and experienced professionals matching the functional tracks are eligible to apply.
Q: What is the typical interview and shortlisting workflow?
Answer: The recruitment process consists of profile shortlisting by talent acquisition, technical evaluations focusing on analytical and regulatory knowledge, and a formal HR discussion followed by academic/employment verification.
Answer: The recruitment process consists of profile shortlisting by talent acquisition, technical evaluations focusing on analytical and regulatory knowledge, and a formal HR discussion followed by academic/employment verification.
Related Career Pathways & Functional Specializations
Associated functional specializations and recruitment tracks for Drug Safety Associate I (Pharmacovigilance) at Qinecsa Solutions:
Qinecsa Solutions Recruitment 2026Qinecsa Solutions Careers IndiaQinecsa Solutions Drug Safety Associate I (Pharmacovigilance) VacancyDrug Safety Associate I (Pharmacovigilance) Jobs in Bengaluru, KarnatakaPharmacovigilance Jobs India 2026Argus Safety Database VacanciesICSR Case Processing ExecutiveDrug Safety Associate CareersMedDRA Coding and Narrative WritingAggregate Safety Reporting PSURB Pharmacy Jobs 2026M Pharmacy Pharmacology CareersPharm D Clinical Research OpeningsBSc Life Sciences CareersPharma Jobs in Bengaluru, KarnatakaPharma Speed Post Verified Careers
Application Procedure
- Carefully review the functional eligibility criteria, academic qualifications, and key duties specified for Drug Safety Associate I (Pharmacovigilance) at Qinecsa Solutions above.
- Calibrate your resume to highlight relevant instrumentation, software platforms, or cGMP/GCP regulatory compliance.
- Ensure your contact details, active mobile number, and email address are up to date in your CV.
- Click the official application button below to access the direct employer recruitment portal or HR email channel with zero intermediary charges.
Submit Official Application – Drug Safety Associate I (Pharmacovigilance) at Qinecsa Solutions
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