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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.
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