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Novo Nordisk Hiring for Pharmacovigilance Process Excellence Specialists in Bangalore
Position Overview & Specifications
| Parameter | Official Specifications |
|---|---|
| Hiring Organization | Novo Nordisk |
| Designation / Role | Pharmacovigilance Process Excellence Specialists |
| Functional Department | Pharmacovigilance (PV) |
| Work Location | Bangalore |
| Experience Requirement | 5+ Yrs |
| Target Qualifications | B.Pharm, M.Pharm, Pharm.D, BDS, MBBS, M.Sc Life Sciences |
| Application Procedure | Direct Official Online Submission / HR Notification |
Key Roles & Detailed Responsibilities
- Execute core operational deliverables for Pharmacovigilance Process Excellence Specialists aligned with Novo Nordisk’s SOPs and compliance frameworks.
- Perform scheduled assessments, data verification, laboratory tests, or regulatory reviews as assigned.
- Maintain audit-compliant documentation and coordinate closely with cross-functional project leads.
- Adhere strictly to global regulatory mandates (cGMP, GCP, ALCOA+ principles).
Eligibility Criteria & Candidate Profile
- Educational Qualification: B.Pharm, M.Pharm, Pharm.D, BDS, MBBS, M.Sc Life Sciences from an accredited university.
- Experience Level: 5+ Yrs in relevant healthcare, pharma, or clinical research environments.
- Strong domain competencies, documentation precision, and communication capabilities.
- Demonstrated adherence to quality assurance and standard operating protocols.
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 Pharmacovigilance Process Excellence Specialists:
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 Pharmacovigilance Process Excellence Specialists
- Highlight targeted skill keywords relevant to Pharmacovigilance Process Excellence Specialists prominently in your technical skills block.
- Ensure project details and laboratory/clinical instrumentation (e.g. HPLC, Argus, EDC, Veeva) are explicitly listed.
- Keep the resume layout clean, modern, and formatted for high-ranking automated ATS parsing.
Technical Interview Assessment & Guidance
Q: What core technical competencies make you suitable for Pharmacovigilance Process Excellence Specialists at Novo Nordisk?
Authoritative Answer: Discuss your hands-on experience, academic foundation, understanding of standard workflows, and compliance awareness.
Authoritative Answer: Discuss your hands-on experience, academic foundation, understanding of standard workflows, and compliance awareness.
Q: How do you ensure data integrity and documentation precision in your daily workflow?
Authoritative Answer: Reference ALCOA+ principles, SOP adherence, real-time documentation practices, and prompt deviation reporting.
Authoritative Answer: Reference ALCOA+ principles, SOP adherence, real-time documentation practices, and prompt deviation reporting.
Q: Why do you want to join Novo Nordisk in this role?
Authoritative Answer: Highlight Novo Nordisk’s market reputation, quality culture, and your commitment to contributing to their operational goals.
Authoritative Answer: Highlight Novo Nordisk’s market reputation, quality culture, and your commitment to contributing to their operational goals.
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 deadline for Pharmacovigilance Process Excellence Specialists at Novo Nordisk?
Answer: Applications are processed on a rolling basis. Candidates are encouraged to apply as early as possible while the opening is active.
Answer: Applications are processed on a rolling basis. Candidates are encouraged to apply as early as possible while the opening is active.
Q: Are freshers eligible for this specific role?
Answer: Freshers (0 years experience) are welcome if indicated in the experience tag; otherwise relevant domain background is required.
Answer: Freshers (0 years experience) are welcome if indicated in the experience tag; otherwise relevant domain background is required.
Q: Does Pharma Speed Post charge any recruitment fee?
Answer: No. Pharma Speed Post provides 100% free career notifications with zero charges.
Answer: No. Pharma Speed Post provides 100% free career notifications with zero charges.
Related Career Pathways & Functional Specializations
Associated functional specializations and recruitment tracks for Pharmacovigilance Process Excellence Specialists at Novo Nordisk:
Novo Nordisk Recruitment 2026Novo Nordisk Careers IndiaNovo Nordisk Pharmacovigilance Process Excellence Specialists VacancyPharmacovigilance Process Excellence Specialists Jobs in BangalorePharmacovigilance 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 OpeningsMSc Chemistry Jobs Pharma IndustryBSc Life Sciences CareersPharma Jobs in Bangalore
Application Procedure
- Carefully review the functional eligibility criteria, academic qualifications, and key duties specified for Pharmacovigilance Process Excellence Specialists at Novo Nordisk 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 – Pharmacovigilance Process Excellence Specialists at Novo Nordisk
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