Meddra Jobs (NOW HIRING)

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.

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
Activities Include:
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
Activities Include:
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: Describe where this position fits in relation to the rest of the department it resides.
Supervised by Senior DSA
WORKING RELATIONSHIPS/INTERFACES: Describe the primary working relationships (internal & external) and primary interfaces along with the frequency and purpose/nature.
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

EDUCATION & EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.
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 owe 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

Thanks!!
With Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Direct: 732-662-7964 | (W) 732-549-2030 x 219

Inc. 5000 - 2007-2015 (9 Years in a row)