Drug Safety Coordinator

Integrated Resources Inc.; Florham Park (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading staffing firm is seeking experienced pharmaceutical professionals for a role focused on adverse event case processing. The role entails data entry and follow-up, requiring a strong background in healthcare and drug safety protocols. A Bachelor's degree and at least two years of experience are crucial for success in this position.

Qualifications

• Minimum of 2 years’ experience in drug safety.
• Ability to work independently and under supervision.
• Knowledge of US and international regulatory requirements.

Responsibilities

• Entry of adverse event information into the safety database.
• Follow-up with healthcare professionals and consumers.
• Compile regulatory reports such as PADER.

Skills

Strong interpersonal skills

Strong process management skills

Strong communication skills

Working knowledge of drug safety reporting procedures

Education

Bachelor’s degree in healthcare related field

Tools

Argus

MedDRA coding

Job description

A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

• Seeking dynamic, focused and creative individuals to join our growing team

• Looking for experienced pharmaceutical professionals to help us build for the future.

• Will be responsible for several portions of the adverse event case processing workflow including but not limited to receipt, evaluation, registration, partial data entry, documentation, and reporting of adverse event information from Clinical trial and post-marketing adverse event cases in accordance with company SOPs and US and worldwide regulations.

Duties & Responsibilities-

• Entry of AE information into the safety database, executing database queries and reports

• Performing active follow-up via verbal or written contact with healthcare professionals (MDs, RNs, etc.) and consumers

• Coding verbatim AE terms, medical history, laboratory data, and drugs using MedDRA and WHO-Drug dictionaries

• Reconciliation of safety information received from external organizations, exchanged with corporate partners, and obtained from clinical trials

• Train other department staff regarding handling of safety information as needed

• Assist in compiling regulatory reports (e.g., PADER).

• Perform other duties as required.

Qualifications

• Bachelor’s degree. (In healthcare related field or with nursing background is ideal).

• Strong interpersonal skills.

• Strong process management and communication skills.

• Working knowledge of drug safety reporting procedures and both US and international regulatory requirements.

• Ability able to work both independently and under supervision to accomplish objectives within deadlines.

• Minimum of 2 years’ experience in drug safety.

• Experience with safety database systems; Argus and MedDRA coding experience is ideal.