Drug Safety Cover Letter

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

In my previous role, I was responsible for strategic drug safety direction to Clinical Operations and CROs to execute the programs (review safety monitoring plans, ICF safety language, etc.).

Please consider my qualifications and experience:

• Experience in hearing survey of side effects
• Work related to the creation and revision of SOP & Annex "Usage Notes"
• Related experience in a healthcare advantageous, but not essential
• Proficiency with Microsoft program package (Word, Excel, and Powerpoint)
• Experience in use and management of relational databases preferred
• Health Care Professional or equivalent experience preferred
• Good understanding of applicable global, regional, local regulatory requirements
• Microsoft Windows XP, Microsoft Office Suite, Industry recognized safety database

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

In my previous role, I was responsible for medical safety review and/or sign off for wide variety of safety documents, both within Safety and Pharmacovigilance and cross functionally, including clinical study protocols, investigator brochures (IB), clinical study reports (CSRs), reference safety information (RSI), regulatory documents, and other documents for investigational and marketed products.

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

• Working knowledge of 21 CFR Part 11 and computer validation experience preferred
• Compliance with client and global regulatory requirements
• Work collaboratively with (DDSS&A) Management’s team
• Knowledge of aggregate reporting
• Solid understanding of worldwide Post-Marketing and Clinical Trial Adverse Event Regulations including GCP, CIOMS, EMA GVP
• Able to perform basic searches via the internet or other comparable data repositories
• Clinical knowledge of therapeutic areas, patient populations and drug class
• Strong organizational skills with attention to detail and efficient time management skills

I submit this application to express my sincere interest in the drug safety position.

Previously, I was responsible for strategy, guidance, and review of safety surveillance and pharmacovigilance activities for products across therapeutic areas and across a product lifecycle (clinical development and marketed products).

Please consider my experience and qualifications for this position:

• Assists with other safety surveillance related activities as needed
• Committed, self-motivated team player
• Supporting Medical safety team in ongoing review and management of safety information
• Supporting the submission of the aggregate safety reports (eg, PADERs, PSURs, DSURs)
• Contributing to the development/revision of other key documents (IB, SDEA, submission dossier)
• Fluency with medical terminology
• Experience in working in a global capacity and responsibility for a global function
• Experience in project management relating to updating and delivering harmonized global processes

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

In the previous role, I was responsible for medical safety review and/or sign off for wide variety of safety documents, both within GLPS and cross functionally, including clinical study protocols, investigator brochures (IB), clinical study reports (CSRs), reference safety information (RSI), regulatory documents, and other documents for investigational and marketed products.

Please consider my experience and qualifications for this position:

• Full time student in a U.S. accredited college or university, currently enrolled in Bachelor’s, Master’s, Pharm
• Major in biology, healthcare, pharmacy, nursing or other life sciences
• Creativity with strong analytical and problem-solving skill
• Proven hands-on experience with safety databases, Argus preferred
• Experience performing and documenting late case investigations preferred
• Experience writing SOPs and other procedural documents preferred
• Working knowledge of global safety reporting requirements preferred
• Experience with Argus, specifically working with submissions and xml files, strongly preferred

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

Previously, I was responsible for medical advice and insights to Therapeutic Area colleagues to improve the quality, consistency, accuracy, and clinical relevance of safety reports.

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

• Lead change management initiatives where there is a need to influence, direct or lead change to prepare the organization for expansion
• Strong process management , communication skills & organizational skills
• Able to manage own work, multi task, plan & organize work assignments and work under timelines
• Computer skills and safety database experience preferred
• Proven pharmaceutical/biotechnology PV experience, including clinical trial and post-marketing experience
• Perform data entry and quality review of adverse event reports into the global adverse event database, including accurate coding of MedDRA terms and preparation of case narratives
• Prepare expedited reports for submission to regulatory authorities and ethics committees
• Interface with quality assurance on product quality issues