Clinical Medical Services Specialist

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 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 our 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 customers.
• Supporting vendor case quality, and productivity metrics by exhibiting the core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One; Decide Smart and Sure.
• Supporting and participating in audits and inspections
• Supporting development of materials and delivering training in conjunction with the vendor, including train-the-trainer, special-topics, refresher, and internal trainings
• 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.
• 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
• Manage shared mailbox, triage escalations, and professionally interact with patients or healthcare providers, including upset callers.
• Participate in cross-functional project work (e.g., training development/implementation).
• Provide feedback to vendors and ensure adherence to quality standards.
  
  

Qualifications

• 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).
• Problem-solving skills
• Demonstrates strong (speed and accuracy) documentation skills
• 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
• Experience in pharmacovigilance, case processing, or call center oversight is preferred.
• Experience with vendor quality oversight and clinical trial safety case processing
• Ability to handle escalations, communicate professionally, and work independently.
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.