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Product Integrity Specialist

Propharma
1-3 years
INR 3-5 LPA
United States, Canada
10 June 17, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, CPT, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, HCPCS Level II, ICD-10-CM, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICD-10-PCS, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Role Overview

The Product Integrity Specialist plays a critical role in managing and reviewing:

  • Product Complaints (PC)

  • Adverse Event (AE) Reports

  • Medical Information Cases

  • Product Retrieval Activities

  • Reconciliation Reporting

This role ensures that safety and quality-related information is accurately documented, reviewed, followed up, and reported in compliance with pharmaceutical industry regulations and client requirements.

The position is highly detail-oriented and requires strong administrative, communication, data management, and pharmacovigilance support skills.


Experience Required

Educational Qualification

Required

✅ Life Science Graduate

Examples:

  • B.Pharm

  • M.Pharm

  • PharmD

  • B.Sc Biotechnology

  • B.Sc Microbiology

  • B.Sc Life Sciences

  • Nursing

  • Veterinary Sciences

  • Healthcare-related Degree


Also Eligible

✅ Pharmacy Technician

✅ Veterinary Technician

✅ Healthcare-related Qualification


Key Responsibilities

1. Product Complaint Management

  • Review Product Complaint cases

  • Assess complaint information

  • Determine next required actions

  • Update complaint records

  • Ensure complete documentation


2. Adverse Event Management

  • Review Adverse Event reports

  • Identify new safety information

  • Recognize follow-up safety data

  • Escalate information to appropriate teams

  • Maintain accurate case records


3. Follow-Up Activities

  • Conduct outbound follow-up calls

  • Collect additional information from reporters

  • Complete missing case details

  • Support case closure activities


4. Product Retrieval Coordination

  • Coordinate product return activities

  • Track retrieval requests

  • Ensure documentation completion

  • Communicate with stakeholders


5. Case Documentation

  • Create new cases

  • Update existing cases

  • Enter electronic correspondence

  • Maintain database accuracy

  • Ensure compliance with timelines


6. Reconciliation Reporting

  • Generate reconciliation reports

  • Review data consistency

  • Support client reporting requirements

  • Assist with quality checks


7. Inbox & Communication Management

  • Manage Product Integrity inboxes

  • Respond to inquiries

  • Process incoming correspondence

  • Handle voicemails and inbound calls


8. Administrative Support

  • Support Medical Information teams

  • Assist operational activities

  • Maintain documentation records

  • Support audit readiness


Required Technical Skills

Pharmacovigilance & Safety

✔ Adverse Event Identification

✔ Case Processing

✔ Safety Reporting Awareness

✔ Medical Terminology

✔ Drug Safety Concepts


Product Complaint Management

✔ Product Complaint Intake

✔ Product Retrieval Support

✔ Complaint Documentation

✔ Complaint Follow-Up


Medical Information

✔ Medical Inquiry Handling

✔ Customer Support

✔ Documentation Review

✔ Data Entry


Computer Skills

✔ Microsoft Word

✔ Microsoft Excel

✔ Outlook

✔ Adobe Acrobat

✔ Document Management Systems

✔ Safety Databases


Key Competencies

Communication Skills

  • Excellent written English

  • Verbal communication skills

  • Professional phone etiquette

  • Proofreading ability

Analytical Skills

  • Attention to detail

  • Data accuracy

  • Problem-solving

  • Information assessment

Organizational Skills

  • Time management

  • Multi-tasking ability

  • Prioritization

  • Meeting strict timelines

Personal Competencies

  • Self-motivated

  • Proactive mindset

  • Teamwork

  • Adaptability

  • Learning agility


Career Progression

Typical growth path:

  1. Product Integrity Specialist

  2. Senior Product Integrity Specialist

  3. Drug Safety Associate

  4. Pharmacovigilance Associate

  5. Senior PV Associate

  6. PV Specialist

  7. PV Team Lead

  8. Drug Safety Manager


Ideal Candidate Profile

A Life Sciences or Pharmacy graduate with 1–3 years of experience in Medical Information, Pharmacovigilance, Product Complaints, Drug Safety Operations, or Healthcare Administration.

Candidates with strong documentation skills, attention to detail, experience handling safety-related information, and excellent written English communication will be highly successful in this role.


Overall Assessment

Job Level

Entry-Level to Associate-Level Professional

Experience Required

1–3 Years

Function

Pharmacovigilance / Medical Information / Product Complaint Management

Industry

Pharmaceutical / Biotechnology / CRO

Specialization

Drug Safety, Product Complaints, Medical Information

Best Suited For

B.Pharm, M.Pharm, PharmD, Life Sciences graduates, Pharmacovigilance Associates, Medical Information Executives, Drug Safety professionals, and Quality Complaint Handling professionals looking to build a long-term career in global pharmacovigilance and product quality operations.