Safety Associate Cover Letter

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

In the previous role, I was responsible for development of safety risk language, risk management plan, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, safety-focused publication development.

Please consider my experience and qualifications for this position:

• High attention to detail, consistently results-oriented and able to work with a sense of urgency within regulated timelines and environment
• Superior organizational, planning and teamwork skills
• Good judgment to be able to prioritize work effectively, make informed risk-based decisions and appropriately identify issues and implement preventative actions
• Highly proactive with demonstrated initiative in problem-solving and identifying new opportunities to improve quality and efficiency of processes
• BSc/BA preferred or relevant work experience
• Experience in Drug Safety/pharmacovigilance with proficiency with Argus Drug Safety database
• Knowledge of relevant Health Canada requirements for reporting adverse events and Special Access Program requests
• Knowledge of relevant industry SOPs/working practices for pharmacovigilance

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

In my previous role, I was responsible for support to lead product safety physician (LPSP) in activities relating to monitoring and management of product's emerging safety profile.

Please consider my experience and qualifications for this position:

• Able to work flexibly across, priorities, medical areas, geographic regions and different business groups
• An appreciation of the pharmaceutical industry and its challenges
• Excellent personal references
• NFPA Certified Fire Protection Specialist preferred
• Minimum 6 months branded restaurant or food industry experience
• Working knowledge of quality practices and procedures
• Strong ​passion ​for ​great ​food ​and ​hospitality
• Safety database experience.drug

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

Previously, I was responsible for support in the collaboration activities (e.g., Medical Safety inputs and opinions on safety issues, Health Hazard Evaluations / Medical Safety Assessments, Medical Safety position in QRBs) with MSOs, RMSOs, Regulatory Affairs and Quality Assurance and Compliance for management of regulatory.

Please consider my qualifications and experience:

• Familiarity and understanding of medical terminology
• Fitness for Duty –FFD- support company-wide), investigations to meet Public Service Commission requirements, medical providers and union leadership for random drug and alcohol testing process, rules compliance for Pipeline Hazardous Materials Safety Administration, ILDNR and IL Emergency Management
• Previous experience developing facility programs and providing EHS training
• Thorough knowledge of the Food and Drugs Act, Food and Drug Regulations and related regulations
• English– fluent written and verbal communications, French an asset but not requirement
• Interact positively with visitors and team members
• Have a working knowledge of Cal-OSHA regulations
• Experience in dealing directly with customers and/or patients

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

In the previous role, I was responsible for support to Global Safety Officer/Lead Safety Physician (GSO/LSP) in activities relating to monitoring and management of Product's emerging safety profile.

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

• Basic understanding of epidemiology data, preferred
• Associate Safety Professional, Certified Safety Professional or Certified Industrial Hygienist
• Occupational Health and Safety Management System experience (e.g., OSHA VPP, OHSAS 18001, ANSI Z10, ISO 45001)
• Multi-site experience and/or providing subject matter expertise remotely
• Enterprise/Corporate policy and procedure development
• Laboratory/Research Safety
• Industrial Hygiene exposure assessments and sampling
• Experience using EHS information technology software

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

In the previous role, I was responsible for in-line medical assessment of individual case safety reports in the context of the available safety data and the known safety profile to assess expectedness and formulate a company statement and a causality assessment.

Please consider my experience and qualifications for this position:

• Assist with development and conduct of safety presentation for start-up meetings, Investigator meetings and other meetings
• Working knowledge of Federal/State regulations and laws regarding Safety & Health Compliance
• Strong customer service /phone skills and/or experience
• Working knowledge of FDA Quality System regulations and application of Good Manufacturing Practices
• Good knowledge of MS Office (Word, Excel, Access, PowerPoint, prior database experience preferred)
• Experience in coding medical data (adverse events and concomitant medications) and understanding of the clinical coding process is preferred
• Working knowledge of MedDRA, and WHODD is strongly preferred
• Problem solving skills should involve identification of problems and proper escalation to Coding management