Pharmacovigilance and Patient Safety Associate

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🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $74k - $85k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 H1B Visa Sponsor

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Veristat

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏥 Healthcare

💊 Pharmaceuticals

💰 Private equity on 2021-05

Consulting • Healthcare • Pharmaceuticals

Veristat is a clinical development services company that provides end-to-end, regulatory-focused support for biopharmaceutical and medical device sponsors. The firm offers full-service clinical trial planning and conduct, regulatory affairs and submission support (including NDA/MAA and interactions with agencies like PMDA), statistical and biometrics services, medical writing, pharmacovigilance, and project management for complex therapeutic areas such as oncology, rare diseases, neurology, biologics, and cell & gene therapies. Veristat operates as a B2B partner to biotech and pharmaceutical organizations to reduce development risk and accelerate regulatory approval.

📋 Description

• Process and manage serious adverse events • Oversee study patients’ safety matters • Work closely with other departments, sponsors, and investigator sites • Ensure proper plans are in place to appropriately collect and report Adverse Events (AEs) and Serious Adverse Events (SAEs) • Facilitate the development and implementation of training programs for internal and external personnel managing safety information • Assist the department head in managing relevant safety group activities

🎯 Requirements

• Bachelor’s Degree in a science or related field required • 2-4 years of pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required • Proficient with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines • Knowledge of medical terminology, clinical trials, and clinical research • Excellent project management, written and oral communication, organizational, and interpersonal skills • Familiarity with and ability to effectively utilize safety databases • Proficiency in English (written and verbal) required • Ability to build and lead effective project teams, motivate others, delegate, and make and implement decisions • Ability to build and maintain trust and confidence and communicate effectively with clients, external vendors, and internal team members • Ability to mentor and delegate

🏖️ Benefits

• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans • Applicable bonus