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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in drug safety data management, including processing Adverse Drug Reactions and regulatory submissions, while ensuring high accuracy and adherence to quality control standards. Proficient in analyzing medical information and effectively communicating with stakeholders in the pharmaceutical and biotechnology industries.
Highest-signal resume keywords
Drug Safety Data ManagementAdverse Drug Reaction ProcessingRegulatory SubmissionsPharmacovigilance PracticesMicrosoft Office Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Adverse Drug Reaction ProcessingSafety ExperienceData ManagementClinical Data EntryRegulatory SubmissionsQuality ControlMedical Information AnalysisCall IntakeCase Follow-UpNarrative Generation
Soft Skills
Good Written CommunicationGood Verbal CommunicationAttention to DetailTeam PlayerAbility to Work Independently
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryCRO IndustryMedical AffairsClinical Data ManagementICH GCP GuidelinesSafety DatabasesQuality AssuranceBiological SciencesLife Sciences
About the role
Key responsibilities & impact- Respond to medical information queries, product quality complaints, and general queries received by telephone, email, fax, and other channels
- Receive, record, and report Adverse Drug Reactions within required timelines according to regulations and internal WI/SOPs
- Execute drug safety data management processes, including call intake, call dialogue documentation, peer review, and case follow-up
- Perform and support assigned activities, including tracking information and metrics, ongoing quality control of defined process steps, training, and reconciliation of data from multiple sources
- Assume responsibility for the quality of processed data
- Perform other duties as needed or assigned
Requirements
What you’ll need- Bachelor’s or Master’s in Pharmacy, Life Science, Medical Science, or related area plus 1–2 years of safety experience
- BS/BA plus 1–2 years of safety experience
- MA/MS/PharmD plus 1–2 years of safety experience
- Associate degree plus 3–4 years of relevant experience or 2 years of safety experience
- Non-degree plus 4–5 years of relevant experience or 2 years of safety experience
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
- Safety experience including processing AE/SAE reports, generating narratives and queries, working within safety databases, and regulatory submissions
- Relevant experience in the pharmaceutical, biotechnology, or CRO industry, including related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance
- Good written and verbal communication skills
- Ability to receive and manage inbound and outbound 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 and attention to detail
- Ability to function as a team player
- Ability to work independently with moderate supervision
- Experience in call center processes preferred
- Preferred disciplines include Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry
Benefits
Comp & perks- Remote work option
- Office environment or remote work arrangement
- Equal employment opportunity and accommodations support
