Assoc Medical Mgr. Pss

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

**Job Overview**:
Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period.

**Summary of Responsibilities**:

- Undertake primary medical review of cases, including medical assessment of the case for seriousness, listed/labeling, causality, adverse event coding and narrative review.
- Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management.
- Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs.
- Provide training and guidance to the case processing team on medical aspects of case processing.
- Performs secondary medical review (QC role) and retrospective review of cases reviewed (QA role), as required for measuring quality of deliverables, identifying error trends, training needs and areas of improvement.
- Performs aggregate medical review and signal detection/analysis activities, as required.
- Enhances existing client relationships whenever possible.
- Creates, maintains, and assumes accountability for a culture of high customer service.
- Participates in process improvement activities across Company.
- And all other duties as needed or assigned.

**Qualifications (Minimum Required)**:

- Bachelor’s degree in medical science or MD or DO or equivalent degree.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- ** Language Skills**:

- Speaking: English at ILR level 3+ or higher.
- Writing / Reading: English at ILR level 4+ or higher.

**Experience (Minimum Required)**:

- Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures.
- Knowledge and understanding of regulatory requirements for Clinical Research.
- Knowledge and understanding of ICH-GCP guidelines.

**Preferred Qualifications Include**:

- Good understanding of regulatory requirements relating to Pharmacovigilance.
- Up to 2 years pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and/or clinical research.
- 1 to 2 years of clinicial practice experience.

**Physical Demands/Work Environment**:

- Office or home-based environment, as requested by the line manager.

**Fortrea is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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