Safety & Pharmacovigilance Specialist I – Medical Device & Product Quality Complaint (PQC)
Company: Syneos Health®
Location: Hyderabad, Telangana, India
Work Mode: Office-Based
Department: Safety & Pharmacovigilance
Employment Type: Full-Time
Experience Required: 2.5–4 Years
Salary Package
Expected CTC: ₹6 LPA – ₹12 LPA (Estimated market range based on pharmacovigilance experience, PQC case handling expertise, safety database experience, and organization. Actual compensation may vary.)
Job Summary
The Safety & Pharmacovigilance Specialist I – Medical Device & PQC is responsible for end-to-end Individual Case Safety Report (ICSR) processing, Product Quality Complaint (PQC) case management, safety data review, regulatory reporting support, and compliance with global pharmacovigilance requirements.
The role requires strong expertise in medical device safety cases, product quality complaints, adverse event processing, safety database management, and regulatory compliance across clinical trial and post-marketing environments.
Key Responsibilities
ICSR Processing & Case Management
Process Individual Case Safety Reports (ICSRs) according to company SOPs, Work Instructions, and project-specific safety plans.
Enter and track safety cases within pharmacovigilance quality and tracking systems.
Perform ICSR triage and assess cases for:
Completeness
Accuracy
Seriousness
Expectedness
Regulatory reportability
Enter safety case information into databases such as:
Oracle Argus Safety
ARISg
Perform medical coding of:
Adverse Events
Medical History
Concomitant Medications
Laboratory Investigations
using MedDRA and relevant coding dictionaries.
Prepare medically accurate and comprehensive case narratives.
Identify missing, inconsistent, or unclear information and manage follow-up queries.
Perform duplicate case checks and duplicate management activities.
Conduct quality review of processed ICSRs.
Regulatory Reporting & Compliance Activities
Support preparation and submission of expedited safety reports according to global regulatory requirements.
Ensure accurate and timely safety reporting activities.
Validate and maintain xEVMPD product records with appropriate MedDRA coding.
Perform manual coding of uncoded product and substance information from ICSRs.
Support SPOR and IDMP-related pharmacovigilance activities.
Maintain safety tracking records for assigned projects.
Ensure proper documentation filing within:
Trial Master File (TMF) for clinical studies
Pharmacovigilance System Master File (PSMF) for post-marketing programs
Apply regulatory intelligence and global safety reporting requirements during case processing activities.
Literature Review, Audit & Stakeholder Collaboration
Perform scientific literature screening and safety evaluation activities.
Support drug dictionary maintenance and coding activities.
Ensure compliance with:
SOPs
Work Instructions (WIs)
ICH Guidelines
GCP requirements
GVP requirements
Global drug, biologic, and medical device safety regulations
Participate in audits and maintain inspection readiness.
Build effective working relationships with internal teams, clients, and external stakeholders.
Support continuous improvement initiatives within pharmacovigilance operations.
Required Qualifications
Educational Qualification:
B.Pharm
M.Pharm
PharmD
BDS
BMS
MBBS
(B.Sc / M.Sc candidates are not eligible as per the job requirement.)
Minimum 2.5–4 years of Pharmacovigilance experience.
Minimum 1 year of hands-on Product Quality Complaint (PQC) case handling experience.
Experience managing medical research-related safety cases.
Hands-on experience with pharmacovigilance databases:
Oracle Argus Safety
ARISg
Required Skills
Strong knowledge of end-to-end ICSR lifecycle management.
Experience in medical device safety and product quality complaint processing.
Knowledge of global pharmacovigilance regulations and reporting timelines.
Experience with MedDRA coding and safety data management.
Understanding of clinical trial phases II–IV and post-marketing safety surveillance.
Strong attention to detail and data quality focus.
Excellent documentation and medical writing skills.
Ability to manage multiple safety cases within regulatory timelines.
Proficiency in Microsoft Office applications, especially Excel and Word.
Strong communication and stakeholder management skills.
Preferred Skills
Experience supporting global pharmaceutical, biotechnology, or medical device safety programs.
Knowledge of GVP modules, ICH E2 guidelines, and device vigilance requirements.
Experience with expedited reporting and regulatory submissions.
Familiarity with xEVMPD, SPOR, and IDMP requirements.
Experience supporting audits, inspections, and client deliverables.
Knowledge of safety analytics and pharmacovigilance compliance metrics.
Career Opportunity at Syneos Health
Opportunity to work with global pharmaceutical and healthcare clients.
Exposure to medical device safety, clinical research safety, and post-marketing surveillance.
Professional development through technical training and career progression programs.
Collaboration with global pharmacovigilance experts.
Opportunity to contribute to patient safety and healthcare innovation.
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