Intermediate (2-5 years of experience)
Summary of the Role
As a Drug Safety Specialist, you will be responsible for monitoring and reporting adverse events and other drug-related risks to ensure the safety and efficacy of pharmaceutical products. You will work with healthcare professionals, regulatory agencies, and internal teams to collect, analyze, and disseminate safety information.
Required Skills
Excellent communication and interpersonal skills.
Proficiency in data analysis software and database management.
Ability to work in a fast-paced and deadline-driven environment.
Strong understanding of clinical terminology and drug development processes.
Detail-oriented with the ability to prioritize tasks efficiently.
Qualifications
Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related field.
2-5 years of experience in drug safety or pharmacovigilance.
Familiarity with regulatory requirements for drug safety reporting.
Experience with drug safety databases and case processing.
Strong analytical and problem-solving skills.
Responsibilities
Monitor adverse event reports and other safety information.
Prepare and submit safety reports to regulatory agencies.
Perform data analysis to identify safety signals and trends.
Collaborate with healthcare professionals to gather detailed safety information.
Assist in the development and implementation of risk management strategies.
Provide pharmacovigilance input on clinical development programs.
Maintain knowledge of relevant regulations and guidelines.