Director – Pharmacovigilance

Job not on LinkedIn

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $200k - $240k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 8%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Lead and develop the pharmacovigilance safety function • Provide direct guidance to a small, dedicated team and oversee operations end to end • Lead risk management and mitigation activities for assigned products • Lead safety data review and analysis for all products • Provide safety-related content for clinical and regulatory documents • Lead pharmacovigilance inspection preparedness and represent the organization at regulatory inspections • Monitor regulatory changes and update SOPs and documentation to address process gaps • Identify resource and infrastructure needs and contribute to departmental budgets and planning • Represent product safety in cross-functional teams • Lead safety governance with medical monitors and leadership • Lead safety activities for regulatory filings, including meeting requests, briefing books, SAP and TFL review, signal detection, risk identification, regulatory query responses, RMPs, REMS, ISS strategy, and regional safety labeling • Mentor direct reports within the pharmacovigilance function

🎯 Requirements

• Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, MD, or PhD • 10+ years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO, including people leadership experience • Knowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements • Experience with pharmacovigilance risk management, preferably at a commercial-stage company • Proficiency in preparing pre-marketing and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans • Experience with clinical development, risk/benefit analysis, and safety assessment • Strong clinical, analytical, problem-solving, scientific writing, and communication skills • Prior experience working on a BLA/NDA • Hands-on mentality and ability to operate in a small biotech environment • Expertise in analyzing safety data from clinical and safety databases • Experience in MedDRA coding and search strategies • Excellent independent judgment based on knowledge and expertise • Strong personal time management and project management skills

🏖️ Benefits

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