The role involves responding to medical information queries and product quality complaints via telephone, email, and fax. Additionally, the assistant will record and report adverse drug reactions while performing data tracking and quality control tasks.
Summary of Responsibilities:
To respond to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc.
Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over telephone calls, email, fax etc.
Perform and support different activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources.
BS/BA or MA/MS/PharmD or Bachelor’s or Master’s in Pharmacy or Life Science or Medical Science or related area.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
Experience (Minimum Required):
Advanced English level and Intermediate Spanish is a must
Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.
Technical proficiency with Microsoft Office suite applications.
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