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Title : JA- Drug Safety Associate I -362
State : Pennsylvania   Date : Jan 8, 2019
Experience Level :  
Position Type : Drug Safety Associate I      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Horsham, PA


Job Title: Drug Safety Associate I


Duration:  6+ months (extendable) contract on W2



Duties:



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. 

Case processing: 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.

Processes & procedures: awareness of and input to company procedures and guidance 

Completion of all assigned training on company and GMSO procedural documents relating to case processing 

Completion of training relating to relevant PV Agreements for assigned products 

Participate in designated activities to support revision/creation of case processing procedural documents 


Project work: participation in assigned projects, including inspection/audit readiness activities 

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 

Personal development: continuous development of personal skills whether task or competency-related. Activities may include project involvement, technical training, shadowing and/or mentoring others, soft-skill development.

Perform other related duties as required 

Mentoring of other DSAs or staff, as identified 

Maintains compliance with company guidelines and HR Policies 


Skills:


Pharmaceutical industry experience is preferred, 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 are preferred 
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 

Other skills: 

Good verbal and written communication skills 

Good computer skills (Word, email) and familiarity with safety systems 

Knowledge or experience with Excel, PowerPoint, Visio preferred 

0-2 years related experience


Education:


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 Bachelors degree, or with knowledge of pharmacovigilance usually exhibited by minimum 5 years experience in pharmaceutical safety-related role.


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Many Thanks,   

Sree Kanth
Associate Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3 
Princeton , NJ 08540 
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