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Job Title: Medical Reviewer/Safety Reviewer II

Duration: 24 Months Contract (++ possibility of extension based on performance and business needs)

• Bachelor's Degree (4-year degree required)
• Minimum 2 years of bedside patient-care experience (mandatory)
• Active RN License (for nursing candidates)
• Strong clinical judgement and critical thinking skills
• Comfortable working with technology and multiple systems

Preferred Backgrounds

• ICU RN
• ER RN
• Critical Care RN
• Clinical Research Nurse
• Hospital Pharmacist with patient-care experience
• MD/MBBS with direct clinical experience
• Clinical Safety / Drug Safety / Pharmacovigilance experience

Nice-to-Have Skills

• Clinical Trial experience
• Adverse Event (AE) / Serious Adverse Event (SAE) review
• Safety Surveillance
• Pharmacovigilance
• Rave and/or Veeva experience
• Strong Excel and Office skills

Disqualifies

• Less than 2 years of bedside patient-care experience
• No direct patient-care experience
• Retail Pharmacists only (CVS, Walgreens, etc.)
• LPNs
• Candidates requiring sponsorship
• Pure Pharmacovigilance candidates without bedside clinical experience 

Key Responsibilities

• Review clinical trial safety data
• Assess AEs/SAEs, labs, vital signs, medications, and medical history
• Investigate safety events and issue queries to sites
• Write narratives and support safety surveillance activities
• Assist Clinical Safety Associates (CSAs) on assigned studies

Key Takeaway from Hiring Managers

• The most important qualification is 2+ years of bedside clinical experience. Pharmaceutical, Drug Safety, and Pharmacovigilance experience are preferred but will not replace the bedside patient-care requirement.

• Please prioritise sourcing RNs (BSN + Active License) with strong patient-care backgrounds. Hospital Pharmacists and MD/MBBS candidates with direct clinical experience can also be considered.

Job Description :

• Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review of labs, vital signs, cardiac, medications, medical history, and can communicate with Study Lead any findings.?? 
• Provide review of safety-related data from clinical trials for content, quality, potential study level trend identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills. 
• Monitoring of safety-related queries to Investigators. 
• Adheres to regulatory guidance, protocols, departmental processes and policies under minimum supervision. 
• Current with knowledge of ICH, FDA, and EMA regulatory guidance’s affecting safety surveillance.  

Experience/Skills

• Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred. 
• A minimum of 2 years of clinical practice experience is required and 1-year drug safety experience preferred.  
• Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and data assessment.  
• Ability to present accurate and medically sound safety data, both orally and in writing. 
• Effective communication skills in delivering study-related information. 
• Proficiency in Computers (Windows, Word, Excel). 

• Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) , including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organize the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.

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 – These all are subject to applicable eligibility).