Senior Drug Safety Associate (India, Remote, 5pm to 2am Shift)

About the Role

Senior Drug Safety Associate (India, Remote, 5pm to 2am Shift) role at MMS Holdings Inc. You will contribute to drug safety and PV activities, maintain regulatory knowledge, and support delivery of high-quality safety deliverables from a remote India site.

What You'll Do

• Maintain an extensive understanding of regulations and guidance as they pertain to drug safety and PV, including case processing, narrative and/or safety writing.
• Understand clinical trial process.
• Independent Project lead; SME; provides strategic narrative development internally and externally, directly negotiates with client.
• Process cases independently, understands steps involved with case processing.
• Lead creation/updates of high quality deliverables.
• Extensive experience working within a safety database, directly interacts with client, mentors others.
• Expert knowledge of coding with MedDRA and WHO drug dictionary.
• Proficient with QC process, writing tools.
• Proficient with templates, toolbars, and formatting.
• Proficient with MMS and client processes and training; 100% compliant.
• Proficient in understanding impact of updates in related deliverables.
• Independently managing/leading client meetings and CRMs for effective resolutions.
• Proficient with managing a project from start to finish and compliant with process; identifies efficiencies within dept processes.
• Proficient with handling client feedback with appropriate feedback.
• What We're Looking For
• College graduate in scientific, medical, clinical discipline or related field, or related experience, masters or PhD preferred.
• Minimum of 5 years’ experience in drug safety, pharmacovigilance, or similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.
• Nice to Have
• Masters or PhD preferred.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Familiarity with ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.