Global Pharmacovigilance, Signal Manager

Job not on LinkedIn

October 22

🚗 Michigan – Remote

Although this job is listed in Michigan, this company may be open to hiring remote in other states.

💵 $91k - $131k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

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Zoetis

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Biotechnology • Pharmaceuticals • Science

Zoetis is the world's leading animal health company, committed to nurturing the world and humankind by advancing care for animals. With over 70 years of innovation, Zoetis develops a broad portfolio and pipeline of medicines, vaccines, diagnostics, and technologies that span a continuum of care to predict, prevent, detect, and treat animal illnesses. Operating in more than 100 countries, the company supports livestock farmers, veterinarians, and pet owners around the globe. Zoetis is driven by science and their shared passion for the human-animal bond, aiming to create a more sustainable and healthier world for all.

10,000+ employees

Founded 1952

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Lead comprehensive post-marketing surveillance activities including proactive monitoring, adverse event trend analysis, signal detection, and signal management for assigned veterinary products, ensuring compliance with global regulatory standards. • Perform detailed risk assessments and provide scientifically and regulatorily sound recommendations to mitigate safety risks impacting animal health. • Serve as the pharmacovigilance and regulatory affairs expert within cross-functional global teams, ensuring integration of safety data and regulatory intelligence into product lifecycle management and decision-making. • Author and review regulatory submissions and communications. • Maintain and manage technical safety documentation within the global signal management system, ensuring data integrity, traceability, and compliance with worldwide regulatory expectations. • Utilize advanced pharmacovigilance software and data analytics tools to interpret safety data and enhance signal detection methodologies, ensuring alignment with global regulatory frameworks. • Lead initiatives to innovate and optimize signal detection and management processes, incorporating emerging scientific, technological, and regulatory developments from a global perspective. • Champion change management and continuous improvement efforts to optimize pharmacovigilance workflows and tools, promote regulatory compliance, and enhance data quality worldwide. • Advocate for and guide the adoption of new technologies and digital tools that improve operational efficiency, data accuracy, and regulatory adherence across multiple regions. • Provide training and mentorship on pharmacovigilance systems, global regulatory requirements, and best practices, with a focus on the latest international regulations and guidelines. • Support regulatory inspections, audits, and internal reviews by providing expert pharmacovigilance and regulatory affairs input, particularly related to compliance with the 2022 EU regulations and other global standards. • Lead sub-teams to critically evaluate pharmacovigilance processes, identify compliance gaps, and implement effective corrective and preventive actions on a global scale.

🎯 Requirements

• Doctor of Veterinary Medicine (DVM) or advanced degree in a relevant biomedical or animal health discipline • Minimum of 3 years’ clinical veterinary experience or equivalent in animal health industry settings • Proven expertise in veterinary pharmacovigilance with a strong regulatory affairs focus, including signal detection, data analytics, epidemiology, and regulatory submissions • In-depth knowledge of global veterinary pharmacovigilance regulations, including but not limited to the EU Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), UK Benefit-Risk Submission Report (BRSR) Guidance, as well as regulatory frameworks in North America, Asia-Pacific, Latin America, and other key markets • Demonstrated experience preparing and interpreting regulatory submissions and managing compliance within a highly regulated, multinational environment • Proven ability to lead change management and continuous improvement initiatives in pharmacovigilance and regulatory affairs • Experience with digital transformation and adoption of innovative technologies in pharmacovigilance or related fields • Strong scientific and regulatory communication skills, with the ability to articulate complex safety and regulatory information clearly and accurately to diverse global audiences • Excellent organizational skills and proven ability to collaborate effectively within multidisciplinary and cross-functional global teams.

🏖️ Benefits

• healthcare • dental coverage • retirement savings benefits • paid holidays • vacation • disability insurance