Drug Safety Associate Cover Letter

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

Previously, I was responsible for technical expertise in accordance with regulatory guidelines on safety-related compliance projects, safety management systems development and implementation, safety oversight, industrial hygiene monitoring and safety auditing.

Please consider my qualifications and experience:

• Excellent technical skills (eg, word processing, spreadsheets, charts/graphs, databases, and online research)
• Strong working knowledge of pharmacovigilance regulations (GVP, ICH, GCP)
• General experience with creation and management of contracts
• Excellent attention to detail, judgment, and problem solving skills
• Internal contacts include Global Drug Safety, Marketing, Regulatory Labeling, Regulatory Affairs, Medical Affairs, Quality, Local Country Personnel, Procurement and Legal
• External contacts include PV Business Partners, vendors and service providers
• Qualified physician (Licence, GMC registered, preferred)
• Solid understanding of regulations impacting Pharma industry in the US and globally, especially drug safety/ PV

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

In my previous role, I was responsible for support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, ICFs, CSRs, IBs and other documents as needed.

Please consider my qualifications and experience:

• Strong (speed and accuracy) computer/ documentation skills
• Any PharmDs submitted should have experience within a clinical health care environment
• Drug Safety/Pharmacovigilance experience with clinical trial case processing preferred
• Previous experience in performing database searches and creating reports out of a database
• Understanding of Pharmacovigilance terminology is an advantage
• Understanding of data structure of a PV database (experience with ARISg is an advantage)
• Good knowledge of MS Excel (pivot tables, v-lookups, macros, etc), basic SQL knowledge is an advantage
• Previous experience in customer service and/or interactions with external customers

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

In my previous role, I was responsible for safety content for regulatory filings, including review of the safety and benefit risk sections, review and preparation of relevant safety sections to ensure consistency across documents and support response preparation.

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

• Assessing data
• Minimum Bachelors of Science or Health Care Professional (RN, BSN, Nurse Practitioner or Physician Assistant, RPh)
• Health care professional - PharmD or Physician
• Global pharmacovigilance experience
• Consumer health background
• Flexible to working with many different compounds
• Medical writing/literature review experience
• Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests

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

Previously, I was responsible for leadership and strategic input for the Drug Safety Surveillance Team in all aspects of pharmacovigilance including the triage and processing of adverse events (AEs), technical/quality complaints, medical/technical inquires, production of periodic safety reports and patient risk management plans; signal detection and safety related queries including those regulatory in nature.

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

• Experience updating/ maintaining controlled documents preferred
• Experience in a document management system preferred
• Experience updating/maintaining training curricula preferred
• Strong working knowledge of GCP related to clinical safety documentation and ICH guidelines
• Understanding and knowledge of commercial and major medical insurance programs, billing requirements, healthcare benefit investigation processes, prior authorization and appeal filings
• Health care professional, ideally physician
• Understanding of cGMPs and pharmaceutical industry procedures and regulations
• Robust project management skills and computer proficiency

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

Previously, I was responsible for content for the safety sections of regulatory documents including IND and NDA submissions or product labeling.

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

• Review and process safety events (pre-marketing, post-marketing, device and drug) and/or other medically related information per assigned tasks and project specific procedures
• Generation of project specific procedures
• Act as Pharmacovigilance lead for regional projects, or assist as needed with global projects
• Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER
• Actively identify out of scope activities
• Train/Mentor Drug Safety Associate staff
• Participation in interdepartmental activities
• Assist management with weekly and monthly project status reports including quality review findings and metrics