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.
- Execute drug safety data management processes – a combination of call intake, call dialogue documentation, peer review, case follow-up.
- 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):
- Bachelor’s or Master’s in Pharmacy or Life Science or Medical Science or related area + 1 to 2 years of safety experience.
- BS/BA + 1 to 2 years of safety experience.
- MA/MS/PharmD + 1 to 2 years of safety experience.
- Associate degree + 3-4 years relevant experience** (or 2 years safety experience).
- Non-degree + 4-5 years relevant experience** (or 2 years safety experience) * .
- 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.
Preferred Qualifications Include:
- Degree preferred (but not necessary) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
- Experience in call center process is preferred.
Physical Demands/Work Environment:
- Office Environment or remote.
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