Clinical Medical Services Specialist

Location: Remote (US)

Contract Length: 24 Months

Pay Rate: 35-40/hr including individual healthcare coverage

Candidates MUST have previous experience within a post-marketing case processing role (2+ years)

• Experience of processing ICSRs
• Knowledge of ICH, FDA, EMEA, and MHRA regulations
• Previous experience in Drug Safety, Pharmacovigilance, and/or Adverse Event roles

Job Description

Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event information (clinical and post marketing) is performed in a compliant and timely manner to comply with global regulations including:

• Seriousness assessment
• Labeling
• Causality
• Initial and Follow-up

Conducting oversight of vendors to ensure company standards for quality, compliance and productivity are met. Remaining current on knowledge and skills required for case processing.

Supporting vendor case quality, case processing metrics and agility using the comapny core leadership attributes.

Supporting development of materials and delivering training in conjunction with the vendor, including train-the-trainer, special-topics, refresher, and internal trainings as needed.

Qualifications:

Minimum:

• Bachelor’s degree in Life Science. RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred. Candidates lacking the appropriate degree but with previous pharmaceutical experience may be considered.
• 2-4 years clinical experience or 2-3 years clinical experience and 1-year pharmacovigilance experience.
• Demonstrates ability to lead project work. Proven success in results-driven process management.
• Demonstrates ability to work collaboratively in team environment.
• Demonstrates understanding of the changing regulatory environment and impact to case management process
• Core knowledge of industry regulations (ICH, FDA, EMEA, MHRA).
• Competent in case processing processes, procedures, conventions.

Provides medical support with emphasis on the intake of medical product experiences and processing standard communication requests.

Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved. Works with Customer Service to provide standard information and product replacement as necessary.

Provides assistance to the medical and lay community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information/indications.