Associate, Pharmacovigilance Operations – Drug Safety

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $90k - $115k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

⚙️ Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 3%

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Orca

WebsiteLinkedInAll Job Openings

11 - 50 employees

💳 Fintech

₿ Crypto

💸 Finance

Fintech • Crypto • Finance

Orca is a platform that facilitates trading and liquidity provision by leveraging the speed of Solana blockchain technology on the Ethereum network. It allows users to trade, manage portfolios, and connect their wallets on the Eclipse network. Designed to provide a seamless experience by combining Ethereum's ecosystem with Solana's rapid processing capabilities, Orca targets users interested in cryptocurrency trading and liquidity solutions.

📋 Description

• Review adverse events and assist in determining regulatory reporting for assigned investigational products • Serve as liaison to internal and external stakeholders for adverse event reporting issues • Collaborate with data management, clinical operations, regulatory affairs, quality, and medical affairs • Serve as main point of contact for adverse event questions, requests, and reviews within safety and clinical databases • Review incoming initial and follow-up SAE/AESI reports and issue clinically appropriate queries • Perform quality control checks and finalize cases entered in the Argus database • Oversee case processing vendor and monitor KPIs for vendor assessment • Address safety database issues and generate Help Desk tickets when appropriate • Assist with preparation of safety reports for regulatory agencies • Assist with literature review as required • Evaluate data points and generate follow-up queries within protocol timelines • Ensure AE reports are complete, accurate, legible, and consistently assessed • Apply FDA and ICH guidelines during case reviews • Contribute to coding medical terms, procedures, and concomitant medications • Maintain contemporaneous eTMF status for relevant safety communications and documents • Generate scheduled and ad hoc safety database reports for the clinical team • Provide subject matter expertise on adverse events • Attend and contribute to internal meetings • Assist with projects assigned by the direct supervisor or PV department leadership • Review and create Safety Management Plans, safety summaries, and SAE reconciliation documents

🎯 Requirements

• A minimum degree of bachelor's or higher degree in a clinical or closely related field • 2-3 years of related experience gained in a biotech or pharmaceutical company • 1-2 years of experience in cellular therapy, stem cell transplant, and/or oncology strongly strongly preferred • Post-marketing experience desirable • Proficiency in the Argus safety database system • Working knowledge of MedDRA and WHODrug coding preferred • Veeva Vault experience preferred • Excellent written and verbal communication skills • Strong attention to detail • Excellent organizational and prioritization skills • Ability to work independently and in a team setting • Ability to manage day-to-day operations as well as special projects within a growing company • Fluent in medical terminology, preferred

🏖️ Benefits

• Pre-IPO equity • Annual bonus • Medical benefits • Dental benefits • Vision benefits • PTO • 401(k) plan • Life and accidental death and disability coverage • Parental leave benefits • Subsidized daily lunches and snacks at on-site locations