Drug Safety Manager

Job Summary:

We are seeking a highly skilled AD, Drug Safety with specialized expertise in Safety Database Management (ARGUS), Safety Operations, PVA/SDEA (Periodic Safety Update Reports/Safety Data Exchange Agreements), and vendor oversight within the pharmaceutical industry. The ideal candidate will have a strong background in pharmacovigilance and drug safety, ensuring compliance with global regulatory requirements and best practices.

Responsibilities:

• Manage and oversee the drug safety database (ARGUS), ensuring accurate and timely data entry, processing, and reporting of adverse events.
• Conduct thorough review and analysis of safety data to identify trends, signals, and potential safety issues.
• Prepare and review PVA/SDEA documents, ensuring compliance with regulatory requirements and internal standards.
• Provide expertise and guidance on pharmacovigilance regulations and industry standards to internal teams and external stakeholders.
• Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, and Medical Affairs to support drug safety activities throughout the product lifecycle.
• Conduct vendor oversight activities, including performance monitoring, auditing, and ensuring compliance with contractual obligations.
• Participate in risk management activities, including signal detection, risk assessment, and risk minimization strategies.
• Contribute to the development and implementation of pharmacovigilance processes, procedures, and training programs.

Qualifications:

• Bachelor's degree in Pharmacy, Life Sciences, Nursing, or related field required; advanced degree (PharmD, PhD) preferred.
• Minimum of 8 years of experience in drug safety/pharmacovigilance within the pharmaceutical industry.
• In-depth knowledge of pharmacovigilance regulations (FDA, EMA, ICH guidelines) and experience with global safety reporting requirements.
• Proficiency in using safety databases (ARGUS preferred) and other pharmacovigilance software/tools.
• Strong analytical skills with the ability to interpret complex safety data and communicate findings effectively.
• Proven ability to manage multiple projects and priorities in a fast-paced environment.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across different functions and levels of the organization.
• Experience in vendor management and oversight is highly desirable.
• Certification in pharmacovigilance (e.g., RPh, Certified Pharmacovigilance Professional) is a plus.