Drug Safety Associate I

Integrated Resources Inc. • Horsham, Montgomery County, United States • $200k - $250k / year • 1w ago

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

Responsible for the receipt and data entry of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.

PRINCIPAL RESPONSIBILITIES:

Case processing: 95%
Definition: The completion of full case information on the database, including quality review to ensure accuracy and completeness

May Triage and classify ICSRs for report type, seriousness, causality, expectedness/labeling and reporting; prioritize ICSR according to regulatory requirements
Confirmation of Safety Coordinator case registry data
Database searches as necessary
Completion of remaining case data entry, including narrative or auto-narrative
Completion of risk and quality (label, approval, manual coding and quality review steps).
Clarification of unclear or illegible information from the LSO or Call Centre
Discussion of source documents, coding conventions and ad-hoc queries with Pharmacovigilance Physician
Request deletions as necessary
Single case unblinding

Processes & Procedures:

Definition: Continuing awareness of company procedures and guidelines to maintain regulatory compliance

Standard Operating Procedures and Working Instructions
Department guidance documents
MedDRA coding dictionary and MedDRA Points to Consider
Understand relevant safety implications regarding contracts with operating companies and/or marketing partners

DECISION-MAKING AND PROBLEM-SOLVING:

Application and knowledge of Departmental processes and guidelines, regulations and regulatory guidelines, contractual arrangements, product specific information and database/systems functionality to individual case processing and evaluation. Communicate questions clearly and concisely to the appropriate audience and accompany with possible solutions.

REPORTING RELATIONSHIPS:

Supervised by Senior DSA

WORKING RELATIONSHIPS/INTERFACES:

Global Medical Safety Operations (GMSO) is a functional area within the Global Medical Organization (GMO)
All others in GMSO
Medical Affairs
Clinical Affairs
Contract Research Organizations
Local Safety Officers
Marketing Partners

Qualifications

EDUCATION & EXPERIENCE REQUIREMENTS:
• Registered Nurse OR
• Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification) OR
• Licensed Practical Nurse without Bachelors degree but with knowledge of Drug Safety usually exhibited by minimum 5 years experience in pharmaceutical safety-related role.
• Pharmaceutical industry experience is preferred

Required Skills/Abilities

• Intermediate Information Technology Skills
• Data entry experience desired
• Accountability for delivery of results
• Decision making skills
• Problem solving skills
• Proactive approach/uses own initiative
• Manages own work, able to prioritize, plan and organize work assignments and work under strict timelines
• Ability to follow guidelines, working practices etc. Experience of working with SOP/WI preferred
• Quality oriented, with attention to detail/accuracy
• Flexibility/Adaptability
• Positive attitude
• Good team player
• Ability to work independently and to collaborate
• Good written and verbal communication skills
• Understanding of medical terminology
• Ability to summarize medical information

Additional Information

Thanks!! With Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Direct: 732-662-7964 | (W) 732-549-2030 x219

#J-18808-Ljbffr