Pharmacovigilance I
Company: Clinztech
Employment Type: Full-time
Schedule: [Day Shift]
Job Responsibilities:
Monitor, collect, and analyze adverse drug reactions (ADRs) and adverse event (AE) reports.
Assist in the processing, assessment, and documentation of safety cases.
Ensure compliance with pharmacovigilance regulations and guidelines.
Conduct literature reviews to identify potential safety concerns.
Support the preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
Assist in signal detection activities to identify emerging safety risks.
Maintain accurate and up-to-date pharmacovigilance databases.
Coordinate with regulatory authorities and stakeholders for safety reporting.
Participate in safety audits and inspections.
Requirements:
Education: Bachelor's/Master’s in Pharmacy, Life Sciences, Medicine, or a related field.
Experience: 0-2 years in pharmacovigilance, drug safety, or clinical research.
Skills:
Knowledge of pharmacovigilance regulations (ICH-GCP, FDA, EMA guidelines).
Familiarity with safety databases (Argus, ArisG, or similar tools).
Strong analytical and medical writing skills.
Ability to interpret and evaluate safety data.
Attention to detail and excellent communication skills.
Preferred Qualifications:
Certification in Pharmacovigilance or Drug Safety is a plus.
Experience in case processing and regulatory submissions.
Why Join Clinztech?
Work with a leading clinical research and pharmacovigilance team.
Competitive salary and career growth opportunities.
Exposure to global pharmacovigilance practices.
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