Position Title: Clinical Medical Services Specialist III
Work Location: 100 % Remote
Assignment Duration: 12 Months
Work Arrangement: Remote
Position Summary
The role focuses on clinical case processing within Global Case Management and pharmacovigilance. The most important requirement is direct experience processing adverse-event cases from pharmaceutical clinical trials.
Background & Context
The team previously used Argus but has transitioned to Veeva Vault Safety. Training, knowledge-management resources, and tools are available to support onboarding. However, candidates are expected to have a strong clinical case processing foundation and up-to-date pharmacovigilance knowledge before joining.
Key Responsibilities
- The contractor will review initial case data entered by the data-entry team, verify the information for accuracy, and manage cases through the required processing steps until release.
- Responsibilities include reviewing adverse-event information, assessing seriousness and causality, evaluating labeling, processing initial and follow-up reports, and coding cases.
- Candidates should be able to read clinical trial protocols, understand study-specific requirements, and apply the relevant pharmacovigilance guidelines to case processing.
- The role includes processing SUSAR cases (Suspected Unexpected Serious Adverse Reactions).
- The team works cross-functionally with colleagues across different locations and values strong communication, attention to detail, teamwork, and the ability to follow detailed guidelines.
Qualification & Experience
- Recent pharmaceutical clinical trial case processing experience.
- Experience handling adverse-event cases and understanding clinical trial protocols.
- Ability to review case data for accuracy and follow cases through completion and release.
- Understanding of pharmacovigilance guidelines and study-specific case processing requirements.
- Ability to assess adverse-event seriousness, causality, labeling, and follow-up information.
- Experience with case coding, including MedDRA coding.
- Strong attention to detail and ability to interpret clinical information using appropriate medical judgment.
- Ability to work independently while collaborating with a cross-functional team.
- Good written and verbal communication skills.
- Experience processing SUSAR cases.
- Hands-on experience with Veeva Vault Safety.
- Experience in initial and follow-up clinical adverse-event case processing.
- Pharmacy, nursing, medical, or other relevant clinical/health-science background.
- Experience working in pharmaceutical clinical safety or pharmacovigilance operations.
- Familiarity with knowledge-management tools and protocol-based case processing resources.
- Experience across multiple therapeutic areas, including oncology and immunology.
- A bachelor's degree in a relevant medical or health-science field is the minimum educational requirement discussed.
- Pharmacy, nursing, and other relevant medical qualifications are acceptable.
- US RN or pharmacist licensure was not considered a strict requirement during the discussion, provided the candidate has the relevant educational background and experience.
- International medical qualifications may be considered.
- Candidates with medical device adverse-event reporting experience alone are less suitable because device reporting differs from pharmaceutical clinical trial case processing.
- Candidates with extensive experience, including PhDs, PharmDs, or physicians, can be considered if they remain comfortable with the hands‑on responsibilities, compensation, and one‑year contract.