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.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- Non-degree + 3-4 years relevant experience** (or 1 yr. safety experience) *
- Associate degree + 2-3 years relevant experience** (or 1 yr. safety experience) *
- BS/BA.
- MA/MS/PharmD.
- 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):
- Good written and verbal communication skills.
- 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.
Physical Demands/Work Environment:
- Office Environment or remote.
Learn more about our EEO & Accommodations request here.