Pharmacovigilance Specialist
Company: Marcyrl Pharmaceutical Industries
Location: Egypt
Department: Pharmacovigilance
Job Type: Full-Time
Experience: 0–1 Year
JOB OVERVIEW
The Pharmacovigilance Specialist is responsible for supporting day-to-day pharmacovigilance operations by managing adverse event reporting, Individual Case Safety Reports (ICSRs), regulatory safety submissions, safety surveillance, and compliance with Good Pharmacovigilance Practices (GVP) and local regulatory requirements. The role involves monitoring product safety, maintaining pharmacovigilance documentation, supporting audits and inspections, collaborating with cross-functional teams, and ensuring timely submission of safety reports to health authorities.
KEY RESPONSIBILITIES
Pharmacovigilance Operations
Perform day-to-day pharmacovigilance activities in compliance with GVP and local regulations.
Support Qualified Person for Pharmacovigilance (QPPV) activities.
Monitor pharmacovigilance compliance across assigned products.
Maintain pharmacovigilance documentation and records.
Ensure timely completion of pharmacovigilance deliverables.
ICSR Management
Collect, validate, and process Individual Case Safety Reports (ICSRs).
Assess adverse events for seriousness and causality.
Perform case follow-up and obtain missing safety information.
Prepare and submit ICSRs within regulatory timelines.
Ensure data quality and completeness of safety cases.
Regulatory Safety Reporting
Prepare and submit Periodic Benefit-Risk Evaluation Reports (PBRERs).
Support preparation of Risk Management Plans (RMPs).
Prepare CIOMS reports, ACOs, DHPCs, and signal notifications.
Submit required pharmacovigilance documents to health authorities.
Track regulatory submission timelines and requirements.
Safety Surveillance
Monitor product safety profiles and emerging safety concerns.
Review safety updates, EURD lists, PVGA announcements, and regulatory communications.
Identify and report potential safety signals.
Support risk minimization activities.
Maintain awareness of evolving pharmacovigilance regulations.
Documentation & Compliance
Maintain the Pharmacovigilance System Master File (PSMF).
Update SOPs and pharmacovigilance procedures.
Archive pharmacovigilance documentation accurately.
Maintain product safety records and documentation.
Ensure inspection-ready documentation.
Audit & Inspection Support
Support internal quality audits.
Assist during regulatory inspections.
Provide required pharmacovigilance documentation.
Address audit observations and corrective actions.
Ensure ongoing regulatory compliance.
Cross-Functional Collaboration
Work closely with Regulatory Affairs, Quality Assurance, and Medical Affairs teams.
Coordinate pharmacovigilance activities across departments.
Respond to regulatory authority requests.
Track PVGA comments and regulatory queries.
Support company-wide pharmacovigilance initiatives.
Training & Awareness
Deliver pharmacovigilance awareness training.
Promote Adverse Drug Reaction (ADR) reporting.
Support employee education on pharmacovigilance procedures.
Encourage compliance with reporting requirements.
Participate in continuous professional development.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor of Pharmacy (B.Pharm)
Bachelor of Medicine (MBBS or equivalent)
EXPERIENCE REQUIREMENTS
Required
0–1 year of Pharmacovigilance experience
Preferred
Knowledge of Good Pharmacovigilance Practices (GVP)
Experience with ICSR processing
Basic understanding of regulatory safety reporting
Knowledge of pharmacovigilance regulations
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