Drug Safety Response Specialist:
Bayer AG

15117-en_US
Bayer AG
Morristown New
Pharmaceutical
Description
  
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change. 

 

Drug Safety Response Specialist 

 
  
  

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Drug Safety Response Specialist, are to: 

 

  • Monitor both the Central and LAM work lists in the Argus Database for follow-up action item requests;

  • Prepare all follow up requests from the Argus Central work list by entering them as action items in Argus LAM;

  • Create appropriate follow up requests (HCP letter, consumer letter, Clinical Trial letter etc) and assign to the appropriate individual for processing;

  • Schedule re-evaluation of follow up requests to determine if required number of attempts have been fulfilled, according to Bayer and regulatory requirements;

  • Generate calls and emails to consumers, healthcare providers and licensed partners in order to obtain critical follow-up safety information;

  • Create and email Clinical Trial letters to study sites requesting follow up information on study participants;

  • Monitor the Drug Safety Response Center mailbox for incoming requests and inquiries, initiate the appropriate process for obtaining follow up information from HCPs and consumers;

  • Communicate and collaborate with global and local colleagues related to safety issues, clarification of requests and encouragement of open communication to achieve mutual understanding of issues and resolutions;

  • Work cooperatively toward the identification of areas needing improvements, make valuable suggestions for improvement and develop continuous improvement methods in order to increase proficiency, accuracy and improve overall compliance within the department.

 

WHO YOU ARE

 

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

  • PharmD or Master's Degree in Life Sciences plus three (3) years of experience in the Pharmaceutical Industry, of which 2 is PV;

  • Bachelor's of Arts or Bachelor's Science Degree in Life Sciences, RN, or RPh with at least four (4) years of medical/surgical nursing or a similar clinical setting; three (3) years of experience in PV required;

  • The incumbent must have demonstrated problem solving skills especially with respect to enforcing safety rules and global procedures as described in SOPs, Operational Manuals and Guidance documents;

  • Knowledge of BHCP GPV processes, GPV SOPs and procedures, GPV global safety database, BHCP rules regarding case processing and knowledge of GPV workflow processes;

  • Experience with global Adverse Events coding dictionaries(MedDRA) and drug coding conventions according to the World Health Organization (WHO);

  • Excellent oral and communication skills are essential, including fluency in English;

  • Excellent interpersonal, decision-making and organizational skills;

  • Proactive behavior and ability to keep timelines;

  • High degree of responsibility and accountability;

  • Ability to develop cooperative working relationships with all levels of staff is critical;

  • Knowledge and respect of cultural differences; professionalism and arbitration are important;

  • Ability to work on international teams;

  • Excellent clinical interpretational skills based on limited information provided along with a strong understanding of medical terminology and MedDRA coding.

 

#KRT

  
YOUR APPLICATION 
  

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

 
  

Bayer is an Equal Opportunity Employer/Disabled/Veterans

  
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.   
  
  
Location:United States : New Jersey : Morristown    
Division:Pharmaceuticals   
Reference Code:15117   
 
 
Contact Us
 
+ 1 888-473-1001, option #5
Basic Qualifications
Requirement