Kelly Services Drug Safety Associate in Horsham, Pennsylvania
Kelly Services has an opening for a Drug Safety Associate in Horsham, PA , this is a one year assignment. The Drug Safety Associate will be responsible for the case processing 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. DSA should have application and knowledge within single case processing context of GMSO processes and guidelines, regulations and regulatory guidelines, contractual agreements, product-specific information and database/systems functionality and be able to
communicate questions clearly and concisely to the appropriate audience, providing possible solutions where appropriate.
Details of job duties:
Completion of full case information on the database, including quality review to ensure accuracy and completeness
Triage of incoming cases to prioritize for daily workflow management
Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
Preparation of SUA summary: Analysis of Similar Events
Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
Other activities relating to case processing as appropriate per case, including but not limited to single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy
Participation in local or global project teams, including on-time delivery of assigned responsibilities
Participation in inspections and audits as identified, including interviews and provision of requested data
Qualifications and requirements:
• Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
• Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
• Licensed Practical Nurse with Bachelor’s degree, or with knowledge of pharmacovigilance usually exhibited by minimum 5 years’ experience in pharmaceutical safety-related role
• Pharmaceutical industry experience with a focus on pharmaceutical safety related areas. Case processing experience is desired
• Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations
Required skills, abilities and competencies include:
• Understanding of medical terminology and ability to summarize medical information
• Ability to follow guidelines and procedural documents (experience of working with SOPs etc. preferred)
• Oriented to quality, attention to detail and accuracy
• Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines
• Ability to work both independently and in collaboration with others
• Proactive approach/uses own initiative appropriately
• Decision-making and problem-solving skills
• Flexibility and adaptability
• Positive attitude
• Good verbal and written communication skills
• Good computer skills (Word, email) and familiarity with safety systems
• Knowledge or experience with Excel, PowerPoint, Visio preferred
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
Perks of being a Kelly employee:
Weekly electronic pay
Access to more than 3,000 online training courses though Kelly Learning center
Group rate insurance options available immediate upon hire*
Service bonus plan and holiday pay*
Online application system
Never an applicant fee
Kelly Services, Inc. is an Equal Opportunity Employer
*perks to be received upon meeting eligibility requirements
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at email@example.com.
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm