Clinical Medical Services Specialist

Description

100 % remote

Job Title: Clinical Medical Services Specialist III

Manager's update

• Must have a bachelor's degree in Pharmacy / Nursing
• Nursing/Pharmacy - either would work (There is no top pick in-between)
• Without Pharmacy/Nursing degree would not going to work.
• PharmD would also work.
• Must have a licensed RN/RPH
• Must have vendor oversight/Vendor Management exp.
• Product Quality Complaints and Adverse Event reporting exp. would be a requirement
• Must drug safety/Pharmacovigilance exp. would be a requirement
• Able to do a quality review
• Must have a good communication skills
• Must have some customer service skills
• Prior QC exp. would be helpful
• Must have case processing exp.
• Soft Skills: Good Communications, Must have a good inter-personal skills, able to handle the email activities

Job Description:

• Conducting oversight of vendors who identify and collect adverse event and product quality complaint information and complete in-take of Pharmacovigilance safety and product complaint reports in Client’s Systems.
• Conducting oversight of vendors to ensure collection, assessment, and processing of adverse
• event and product complaint information is performed in a compliant and timely manner to comply with global regulations.
• Supporting the business strategy of assisting internal and external customers in collecting information for product safety reports, products complaints related to Clientt products.
• Conducting oversight of vendors to ensure company standards for quality, compliance and productivity are met. Remaining current on knowledge and skills required for supporting Client customers.
• Supporting vendor case quality, and productivity metrics by exhibiting the Client core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One Client; Decide Smart and Sure.
• Supporting and participating in audits and inspections as needed.
• Supporting development of materials and delivering training in conjunction with the vendor,including train-the-trainer, special-topics, refresher, and internal Client trainings as needed.
• Conducting oversight to ensure the vendor is effectively communicating using various mediums and establishing rapport with customers, colleagues, and interdepartmental groups.
• Conducting oversight in the vendors use of multiple databases to document adverse event and product complaint information.
• Supporting implementation of strategies to enhance PDI excellence in providing the highest level of customer experience.
• Acts as an adverse event and product complaint intake subject matter expert.
• Other duties may be assigned based on the need or work requirement of the organization.

Experience/Skills:

• Bachelor’s degree of RN, BSN, or BS Pharm/PharmD required.
• 2-4 years’ clinical healthcare and previous pharmaceutical industry experience. Pharmaceutical industry contact center experience preferred.
• Demonstrates ability to lead project work. Proven success in results-driven process management.
• Core knowledge of Industry regulations (ICH, FDA, EMEA, MHRA).
• Demonstrates strong attention to detail and problem-solving skills
• Demonstrates strong verbal communication skills with external and internal customers Demonstrates strong (speed and accuracy) documentation skills

Provides medical support with emphasis on the intake of medical product experiences. 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.

What are the top 3-5 skills, experience or education required for this position:

• Strong attention to detail when reviewing cases and doing quality assessments
• Excellence in verbal and written communication with peers, patients, and HCPs
• Ability to provide feedback in a professional manner
• Strategize in efficiency and technology improvements
• Ability to work in a constantly evolving environment