To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $33 to $37 an hour. (Negotiable)

Client Industry: Pharmaceutical
Job Mode: 100% Remote
Contract Duration: 12 Months (++Possibilities of Extension)

• Bachelor’s degree in a health science–related field
• Minimum 2 years of clinical practice experience
• Ability to apply clinical knowledge to adverse event data assessment
• Experience reviewing clinical or safety-related data
• Knowledge of ICH, FDA, and EMA regulatory guidance
• Strong critical thinking and analytical skills
• Strong written and verbal communication skills
• Proficiency with Windows, MS Word, and Excel

• Review clinical trial safety data including labs, vital signs, cardiac data, medications, and medical history
• Perform medical review of Case Report Forms (CRFs), including query resolution and addendum writing
• Assess safety data for accuracy, quality, protocol compliance, and regulatory adherence
• Identify potential study-level safety trends using critical thinking skills
• Monitor and manage safety-related queries to investigators
• Support adverse event and serious adverse event investigation and documentation
• Collaborate with Clinical, Medical, and Regulatory teams on safety reporting activities
• Review protocols, study summaries, investigator brochures, and safety sections of regulatory documents.

• Registered Nurse (RN) background
• Clinical pharmacy experience
• Prior drug safety or pharmacovigilance experience
• Experience with adverse event reporting and safety surveillance activities
• Experience supporting IND annual updates or regulatory safety documentation
• Experience providing safety training or investigator meeting support.

Benefits:
Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)