Director, Global Drug Safety – Pharmacovigilance Operations

Job not on LinkedIn

🕒 3 days ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

⚙️ Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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Asahi Kasei

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1922

🏥 Healthcare

🏗️ Construction

🍽️ Food & Beverage

Healthcare • Construction • Food & Beverage

Asahi Kasei is a diversified multinational Japanese industrial group that develops and manufactures materials, chemical products, electronic components, homes and building materials, and healthcare and pharmaceutical products. The company conducts R&D and commercial activities across semiconductors/electronics, life sciences and pharmaceuticals, medical devices, and energy technologies such as electrolysis and hydrogen production, while emphasizing sustainability and innovation.

📋 Description

• Lead and provide direction for all product safety and pharmacovigilance activities in compliance with global requirements • Develop GDSPV operations strategy, goals, objectives, implementation, and training • Manage pre- and post-marketing safety surveillance activities throughout product lifecycles • Provide pharmacovigilance leadership for clinical development and postmarketing programs while collaborating with internal and external stakeholders • Prepare and review safety sections of clinical, regulatory, and scientific documents and submissions • Direct creation and maintenance of Core Safety Information and Reference Safety Information • Oversee aggregate safety reports, including PSURs/PBRERs, PADERs, DSURs, IND Annual Reports, and SUSAR line listings • Oversee risk-benefit evaluations and Risk Management Plans • Develop and manage pharmacovigilance activities and safety data exchange agreements with license partners • Govern vendors, including adverse event/product complaint call centers, outsourced ICSR processing, monitoring reports, and safety database operations • Develop and maintain the pharmacovigilance quality system and Pharmacovigilance System Master File • Create and maintain SOPs and working practices for inspection readiness and regulatory compliance • Serve as pharmacovigilance subject matter expert during audits and regulatory inspections • Manage pharmacovigilance budget and forecasting • Support signal detection, safety assessments, and Safety Management Team and Benefit Risk Assessment Team meetings • Represent the company in product safety meetings with license partners and CROs • Provide pharmacovigilance training and manage training compliance • Maintain current knowledge of global regulations and guidelines

🎯 Requirements

• Bachelor’s degree in scientific / technical discipline, RN, or equivalent healthcare experience • At least 7 years’ drug safety experience in the pharmaceutical industry • Strong knowledge of US and EU pharmacovigilance regulatory requirements and current pharmacovigilance practices • Solid experience with drug safety databases, especially with Argus • Solid vendor management/governance experience • Self-motivated, detail-oriented, with the ability to prioritize and plan effectively • Excellent leadership qualities and written and verbal communication skills • Ability to work in a dynamic, fast-paced environment with shifting priorities • Experience with internal audits and global regulatory inspections • Strong organizational and project management skills • Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro • Travel Requirements: <10%

🏖️ Benefits

• Equal opportunity employer committed to a diverse workforce • Remote work arrangement • Travel requirements: <10%

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