Drug Safety Associate (Bangalore, Hybrid)
Drug Safety Associate (Bangalore, Hybrid)
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Job Description
Are you looking to join a company where your contributions truly matter and where youll be part of a supportive innovative teamMMS is a awardwinning datafocused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical biotech and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents MMS not only maintains an industryleading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit follow MMS on LinkedIn.
Job Description
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
Receive prioritize and accurately transfer information from initial and followup source documents of adverse event reports to the appropriate fields in Safety Database
Assess case reports for seriousness causality and expectedness
Code adverse events using MedDRA and accurately advance cases through Safety Database workflow within global and local timelines
Perform triage case initiation and process cases as assigned which includes but is not limited to: receiving and tracking information regarding potential initial and follow up adverse event reports from all sources prioritizing and performing searches for duplicate cases in Safety Database prior to the initiation of the case into Safety Database initiating adverse event reports into Safety Database providing reports to assigned staff members for assessment and assuring that cases are returned to case initiation for distribution within defined timelines
Collect accurate follow up information in a timely manner serious adverse events and other safety reports
Responsible for writing case narratives for Safety Database and for clinical study report
Write and maintain Safety Management Plans for assigned projects
Produce high quality documents
Understand ICH FDA EMA and global regulatory guidelines as applicable to SAE case processing/reporting and medical writing for clinical studies
Strong proficiency with client templates and style guides
Job Requirements (Minimum Education / Experience / Training / Skills)
- College graduate in scientific medical clinical discipline or related field or related experience
- Expert experience in SAE reporting and case processing preferred
- 25yearsexperience 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 multitasking efficiently
- Excellent organizational and communication skills
- Familiarity with 21 CFR Part 11 FDA and GCP requirements
Required Experience:
Manager
Employment Type
Full-Time
