Drug Safety Specialist I (524740)· Morris Plains, NJ
Drug Safety Specialist I (524740)
Morris Plains, NJ
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Job Description
Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have an entry level contract opportunity for a Drug Safety Specialist I for our client in Morris Plains, NJ.
The Drug Safety Specialist I will be 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 include: data management, report preparation and appropriate dissemination of spontaneous non serious and serious adverse event information for legacy consumer healthcare products. Activities include:
- Duplicate check and commit contact information from initial and follow up source documents into the adverse event database
- Forward cross reference email with assigned data base number to reporter for ex US contacts
- Prepare a clinical narrative CIOMS/3500A and independently assign MedDRA terms and labeling to adverse events while maintaining compliance timelines
- Liaise with the SA point person for Triage Quality review (is limited to review of their own work)
- Requests deletions, as necessary
- Supports aggregate report writing via data integrity changes
- All other duties, as assigned
SKILLS
In order to be successful within this role, qualified candidates must be able to understand and follow BRM systems and procedures, have SOP/SWP awareness and knowledge of Guidance Document Forms (GDFs). Candidates must have a working knowledge of data management systems.
In order to be successful within this role, qualified candidates must be able to understand and follow BRM systems and procedures, have SOP/SWP awareness and knowledge of Guidance Document Forms (GDFs). Candidates must have a working knowledge of data management systems.
Excellent oral and written communication skills as well as decision making skills are required. Candidates must be able to manage his/her work with the ability to follow guidelines. An individual with quality orientation, who is flexible/adaptable, a team player with a positive attitude with the ability to collaborate with a group is essential.
EDUCATION/EXPERIENCE
Qualified candidates will have a Bachelors degree and at least 3 years of clinical drug safety experience, including using medical terminology and MedDRA. Applied knowledge of global regulations and global compliance timeline is desired.
Qualified candidates will have a Bachelors degree and at least 3 years of clinical drug safety experience, including using medical terminology and MedDRA. Applied knowledge of global regulations and global compliance timeline is desired.
If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted.
Kelly Scientific Resources has grown into a $270 million global business as the scientific business unit of Kelly Services. Our recruiting consultants place clinical, regulatory and medical affairs, data management and biostatistics professionals to the pharmaceutical, biotechnology, medical device, CRO and university research communities. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com.
Kelly Services is an Equal Opportunity Employer.
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