Drug Safety Manager
Drug Safety Manager
Discover International
United States
See who Discover International has hired for this role
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.
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Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Science and Research -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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