Sr Medical Manager Pss

5+ years
Not Disclosed
10 March 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Review Physician - Drug Safety and Pharmacovigilance

Company: Fortrea, a Global Contract Research Organization (CRO)

Location: [Insert Location]


About Fortrea:

Fortrea is a leading global contract research organization (CRO) that has been delivering scientific rigor and clinical development expertise for decades. We offer a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas, partnering with pharmaceutical, biotechnology, and medical device customers. Operating in nearly 100 countries, we are transforming drug and device development for both partners and patients globally.


Position Overview:

We are seeking an experienced Medical Review Physician to join our Drug Safety and Pharmacovigilance team. In this role, you will be responsible for reviewing serious adverse events (SAEs) and adverse events of special interest (AESIs) from clinical trials to support drug safety activities. You will also be involved in the preparation and medical review of Aggregate Reports, signal detection, and providing pharmacovigilance support to project teams. This role requires substantial expertise in drug safety and global pharmacovigilance regulations.


Key Responsibilities:

  • Provide medical review for serious adverse events (SAEs) and adverse events of special interest (AESIs) from clinical trials to support drug safety activities.
  • Prepare and medically review Aggregate Reports required by global regulatory agencies (when authorized).
  • Perform signal detection and evaluation activities, including preparation and submission of Ad Hoc Reports to global regulatory agencies for safety issues (when authorized).
  • Participate in pharmacovigilance training to enhance knowledge of drug/product development and marketing, utilizing good clinical practice (GCP) guidelines.
  • Offer medical and safety expertise to project teams and communicate changes in drug safety regulations.
  • Review laboratory values, adverse events, coding dictionaries, data tables, listings, and figures to identify drug safety issues in collaboration with the project physician.
  • Assist in the preparation of pharmacovigilance materials for investigator meetings.
  • Provide pharmacovigilance support to project physicians as required.
  • Participate in project risk assessment activities.
  • Take responsibility for medical and safety monitoring on assigned projects.

Education and Qualifications:

Required:

  • MBBS and/or MD with at least one year of clinical medicine or postgraduate training.

Preferred:

  • MD who has completed an accredited residency program or equivalent and is board-eligible or certified, with at least 4 years of experience in drug safety and a strong understanding of global pharmacovigilance regulations.

Minimum Required Experience:

  • At least 5 years of experience in pharmacovigilance or patient safety, working for a pharmaceutical company, health authority, or contract research organization (CRO).

Why Join Fortrea?

At Fortrea, we are driven by a passion for overcoming barriers in clinical trials. By joining our team, you will help shape the future of drug development and have a meaningful impact on patient outcomes. You’ll also find a collaborative environment where your professional growth is supported and valued.


Fortrea is an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea is dedicated to fostering a diverse and inclusive workforce. We do not tolerate harassment or discrimination of any kind and make employment decisions based on the business needs and qualifications of the individual. We encourage candidates from all backgrounds to apply.

For more information on how we collect and store your personal data, please review our Privacy Statement.

If you require a reasonable accommodation due to a disability to complete your job application, pre-employment testing, job interview, or otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this email is for accommodation requests only and should not be used to check the status of your application.


Apply Now to Make a Difference at Fortrea!