[Remote] RCI-ABBV-32073 Pharmacovigilance Specialist / Drug Safety Specialist (RN/RPh/AE/SAE Review/Safety Data Review)

Note: The job is a remote job and is open to candidates in USA. Rangam is seeking a Pharmacovigilance Specialist / Drug Safety Specialist to provide timely assessment of clinical trial data and participate in safety surveillance activities. The role involves reviewing safety-related data, adhering to regulatory guidance, and providing medical support for adverse event reporting. 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 Skills • Nursing or Pharmacy degree needed • RN or RPh license is a must have • Bachelor's degree with related health science background • RN License with Drug safety or Pharmacovigilance exp • RP license needed • 1 year to start • 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) • Clinical pharmacy experience strongly preferred • 1-year drug safety experience preferred Company Overview • 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. It was founded in 1995, and is headquartered in Somerset, New Jersey, USA, with a workforce of 501-1000 employees. Its website is https://rangam.com/. Company H1B Sponsorship • Rangam has a track record of offering H1B sponsorships, with 10 in 2025, 2 in 2024, 4 in 2023, 5 in 2022, 4 in 2021, 9 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply To this Job