Rangam · 19 hours ago
RCI-ABBV-32073 Pharmacovigilance Specialist / Drug Safety Specialist (RN/AE/SAE Review/Safety Data Review)
United States
Contract
Remote
Entry, Mid Level
$35/hr - $38/hr
2+ years expRangam is seeking a Pharmacovigilance Specialist / Drug Safety Specialist to provide timely assessment of reported clinical trial data and participate in safety surveillance activities. The role involves reviewing safety-related data from clinical trials, adhering to regulatory guidance, and providing medical support regarding adverse event reporting.
ConsultingInformation TechnologySoftwareStaffing Agency
Hiring Manager
Sumit Rawat
Responsibilities
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
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 organizes 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
Qualification
Required
Bachelor's degree with related health science background
RN License with Drug safety or Pharmacovigilance experience
RP license
A minimum of 2 years of clinical practice experience is required
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)
Preferred
Clinical pharmacy experience strongly preferred
1-year drug safety experience preferred
Company
Rangam
Rangam is a global, innovative, Total Talent management firm with the mission of accelerating meaningful employment for everyone! We are a minority-, woman-, and disability-owned firm with over 25 years of experience promoting sustainable and inclusive talent programs within our communities and employers.
501-1000 employees
H1B Sponsorship
Rangam has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (2)
2023 (4)
2022 (5)
2021 (4)
2020 (9)
Funding
Current Stage
Late StageLeadership Team
Nish Parikh
Co-founder & CEO
Hetal Parikh
Co-Founder & President
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