Senior Drug Safety Associate - #599023

About MMS

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.

Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.

MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Responsibilities

• Proficiency with drug safety regulations and guidance’s
• Understanding of regulations and guidance as they pertain to drug safety and PV, including case processing, narrative and/or safety writing. Understands clinical trial process
• Generate high quality of case narratives within the stipulated timelines. Acts as Project Lead with or without guidance.
• Process cases with minimal guidance, understands steps involved with case processing. Supports creation/updates of high quality deliverables experience working within a safety database knowledge of coding with MedDRA and WHO drug dictionary
• Proficient with QC process, writing tools and provides mentorship to others.
• Proficient with templates, toolbars, and formatting provides mentorship to others.
• Manage/lead client meetings with or without guidance from senior level colleague.
• Proficient with managing a project from start to finish and compliant with process.
• Proficient with managing a case from start to finish and compliant with process.
• Experienced with identifying and mitigating project risk, including assessing client gaps with or without support from senior level colleague.
• Process adverse event reports within approved timelines as defined in local and global work instructions, SOPs and regulations to meet local and global reporting requirements
• Assess case reports for seriousness, causality and expectedness.
• Receive, prioritize and accurately transfer information from initial and follow-up source documents of adverse event reports to the appropriate fields in Safety Database.
• Code adverse events using MedDRA, and accurately advance cases through Safety Database workflow within global and local timelines
• Perform triage, case initiation and processing duties as assigned. This includes but is not limited to receiving and tracking information regarding potential initial and follow up adverse event reports from all sources
• Prioritize and perform searches for duplicates in Safety Database prior to the initiation of the case into Safety Database, initiating adverse event reports into Safety Database
• Provide reports to assigned staff members for assessment and assuring that cases are returned to case initiation for distribution within defined timelines. Writing case narratives
• Collect accurate follow up information in a timely manner on non-serious and other adverse event reports
• Responsible for writing case narratives and producing high quality documents
• Understand and adhere to reporting obligations by initiating and processing adverse event reports within approved timelines as defined in local and global work instructions, SOPs and regulations to meet local and global reporting requirements
• Demonstrate excellent project coordination skills
• Interact directly and independently with client to coordinate all facets of projects; competent communicator
• Assume responsibility for quality and integrity of deliverables
• Independently implement and validate QC findings in compliance with NC Handling Procedure
  
  

Requirements:

• College graduate in scientific, medical, clinical discipline or related field, or related experience
• Expert experience in SAE reporting and case processing preferred
• 2-5 years experience in the pharmaceutical or CRO industry
• Excellent interpersonal, verbal and written communication skills
• Proficiency with MS Office applications and other word processing software
• Expert knowledge of drug development as pertains to drug safety; has the ability to apply drug development knowledge during production of high quality documents
• Skills in multi-tasking efficiently
• Excellent organizational and communication skills
• Familiarity with current ISO 9001 and ISO 27001 standards preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements