Job Overview
The Medical Contact Center Sr. Specialist will be responsible for responding to medical information queries, product quality complaints, and any general queries that may be received via the Medical Contact Center.
Summary Of Responsibilities
- Receive information, record, and report Adverse Drug Reaction in timelines (according to the regulations and to internal WI/SOPs) that may be received over the telephone call, email, fax etc.
- Execute drug safety data management processes a combination of call intake, call dialogue documentation, peer review, case follow-up.
- Guide Junior associates in managing voice calls (as required).
- Create and revise training materials based on procedural, system, and regulation updates.
- Responsible for conducting training and checks the effectiveness of the training as required.
- Perform and support different activities as assigned tracking several 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.
- And all other duties as needed or assigned.
Qualifications (Minimum Required)
- Bachelor's or Master's in pharmacy or Life Science or Medical Science.
- Associate degree plus 6 to 7 years relevant experience
- *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.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
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.
Preferred Qualifications Include
- Degree preferred (but not necessarily) in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
- Experience in call center operations is preferred.
Physical Demands/Work Environment
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