Medical Contact Center Specialist

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 reporting Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call email faxetc.
• Execute drug safety data management processes a combination of call intake call dialogue documentation peer review case follow-up report preparation and submission to regulatory authorities.
• Create and revise training materials based on procedural system and regulation updates.
• Responsible in conducting trainings and checks the effectiveness of the trainings as required.
• Guide Junior associates in managing voice calls (as required).
• 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.
• Assume responsibility for quality of data processed.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Bachelors or Masters in pharmacy or Life Science or Medical Science or related area 3-4years of safety experience.
• BS/BA 3-4 years of safety experience.
• MA/MS/PharmD 2-3 years of safety experience.
• Associates degree 5-6 years relevant experience** (or 4 years safety experience) * non degree 6-7 years relevant experience** (or 4 years safety experience).*
• Experience in managing call center operations is preferred.
• Degree preferred (but not necessary) to be in one or more of the following disciplines:
• Biological Sciences Pharmacy Nursing Life Sciences and Chemistry.
• 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):

• Good written and verbal communication skills.
• Ability to receive and manage in-bound and out-bound calls.
• Ability to analyze and synthesize medical information.
• Good understanding of regulatory requirements good Pharmacovigilance practices and ICH GCP guidelines.
• Technical proficiency with Microsoft Office suite applications.
• High degree of accuracy with attention to detail.
• Functions as a team player.
• Ability to work independently with moderate supervision.

Physical Demands/Work Environment:

• Office environment or remote.

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