Drug Safety Specialist Cover Letter

I am excited to be applying for the position of drug safety specialist. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data.

My experience is an excellent fit for the list of requirements in this job:

• Monitor both the Central and Local Affiliate Module 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 Local Affiliate Module
• Create appropriate follow up requests (HealthCare Providee letter, consumer letter, Clinical Trial letter, ) and assign to the appropriate individual for processing
• 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 HealthCare Providers 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

In response to your job posting for drug safety specialist, I am including this letter and my resume for your review.

In the previous role, I was responsible for safety data sheet impact assessment and update, as well as MedDRA & WHO Drug code updates and impact analyses.

Please consider my qualifications and experience:

• Intermediate knowledge of research methods and related analyses
• Works effectively with colleagues in matrix organization and facilitates achievement of common goals
• Is adaptable and can work effectively in ambiguous situations
• Willing and able to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
• 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
• 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

Please consider me for the drug safety specialist opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for medical assessment on all cases for seriousness; conducts quality review of cases; conducts follow-up on cases; communicates responses to queries related to drug safety.

Please consider my qualifications and experience:

• 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
• Knowledge and respect of cultural differences
• Excellent clinical interpretational skills based on limited information provided along with a strong understanding of medical terminology and MedDRA coding
• Sound knowledge of databases such as those used for Drug Safety Surveillance and other software applications helpful
• Working knowledge of European Regulations governing SAR report collection, evaluation, processing, and submission for both investigational medicinal products and marketed product appreciate
• Document instances of non-compliance, subsequent interventions and resolution

In response to your job posting for drug safety specialist, I am including this letter and my resume for your review.

In my previous role, I was responsible for supervision of information entered into the safety database ensuring accuracy, consistency of data, and appropriate MedDRA and WhoDrug coding.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Strong knowledge base of pharmacovigilance principles with close attention to detail with the flexibility to meet daily competing priorities, is preferred
• Demonstrates a basic knowledge of Word & Excel
• Comply with all company and regulatory policies and procedures
• Clinical trial or product development experience
• Understanding of basic concepts of clinical pharmacology and toxicology as applied to pharmacovigilance
• Working knowledge of drug development processes and activities
• Working knowledge of medical concepts, terms, conditions, and associated pathology
• Strong analytical thinking to diagnose common situations, gather and review relevant information, and recommend solutions

I would like to submit my application for the drug safety specialist opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for initial medical evaluation of adverse events on company investigational and marketed products by determining the seriousness, expectedness, and therefore reportability of adverse events in line with FDA and global regulatory guidelines.

Please consider my qualifications and experience:

• Evident selling skills
• Active listener and is able to identify important customer needs
• Action oriented in driving for results
• Self-motivated style of working and learning
• Basic computer skills including Microsoft Word, Excel, PowerPoint and Outlook
• Understands local and applicable foreign safety regulations
• Experience with use of safety databases, preferably Argus Safety Database
• Relevant experience within a Pharmaceutical company or CRO