What are the responsibilities and job description for the Medical Reviewer/Safety Reviewer position at Synectics Inc?
Description:
In this role, you will initiate and manage product complaint records in the electronic system, determining investigation needs, leading activities, and documenting reports.
You will gather complaint information by interfacing with external clinical investigators and partner companies.
You will work with manufacturing and quality engineering to conduct investigations and implement CAPAs as needed.
You will assess the risk and impact of complaints on clinical supplies and liaise with Post Marketing Quality to evaluate the reportability of complaints to regulatory agencies.
Additionally, you will ensure consistency between product complaints and adverse event information in collaboration with safety organizations.
Qualifications:
Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
3 years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is preferred.
Proven organizational skills.
Effective use of oral and written communication skills.
Ability to identify and resolve complex problems through effective use of technical and interpersonal skills.
Analytical and investigative mindset
Comfortable with multitasking.
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.
