Clinical Medical Services Specialist

Job Description

Job Description

Job Description:

• Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event information (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 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 as needed.

• Developing knowledge and expertise to initiate mentoring of MSA's in vendor management.

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

• 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.

• Other duties may be assigned based on the need or work requirement of the organization

Qualifications:

• Minimum: Bachelor's degree in Life Science.

• RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred.

• Nursing experience and preferably experience with critical care/ICU/Cardiac/ER.

• Pharmacovigilance experience preferred.

• RNs with clinical and PV experience

• Experience Level = 5-7 Years

• 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.

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 of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities

Company Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities