Adverse event collection and reporting: Receiving and reviewing adverse event reports from healthcare professionals, clinical trials, and other sources.
Case processing: Performing detailed analysis of adverse events, including medical coding using MedDRA (Medical Dictionary for Regulatory Activities) to accurately categorize and classify the events.
Signal detection: Identifying potential safety signals by analyzing patterns in adverse event data, including trends and clusters. Risk assessment: Evaluating the severity and causality of adverse events to determine the potential risk associated with a drug.
Regulatory reporting: Preparing and submitting timely reports to regulatory agencies regarding serious adverse events and safety concerns.
Literature review: Monitoring published medical literature for potential safety concerns related to the drug.
Collaborating with cross-functional teams: Working with clinical researchers, medical affairs, and marketing teams to communicate safety information and address potential safety issues.
Qualifications
Bachelor's degree in a related field, such as pharmacy, nursing, or biology
0-2 years of experience in pharmacovigilance or a related field
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
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Employement Category:
Employement Type: Full timeIndustry: Pharma / BiotechRole Category: Bio Tech / R&D / ScientistFunctional Area: Not SpecifiedRole/Responsibilies: Pharmacovigilance Associate Job in CLIN