Drug Safety Associate II

About the Role

The successful candidate will have a strong background in pharmacovigilance, with a degree in Pharmacy or Nursing and at least 2 years of experience in the pharmaceutical industry. You will be an integral part of the company's safety and pharmacovigilance team, participating in study team meetings, supporting audits and regulatory inspections, and providing coverage of the dedicated adverse event reporting line.

The company is committed to creating an inclusive environment for all employees, with a competitive total rewards package that includes healthcare, life insurance, profit sharing, paid time off, and a matching 401k. If you are a motivated and detail-oriented individual with a passion for pharmacovigilance, this role may be an excellent fit for you.

What You Will Do

• Review, evaluate, and manage adverse event reports for all American Regent, Inc. products
• Perform quality checks on assigned individual case safety reports (ICSRs)
• Reconcile safety data to ensure accuracy and compliance
• Participate in study team meetings as the Safety and Pharmacovigilance representative
• Support audits and regulatory inspections
• Provide coverage of the dedicated adverse event reporting line during company business hours
• Interact with internal and external customers to ensure timely and effective communication
• Maintain corporate compliance and adhere to regulatory requirements
• Perform any other tasks or duties as assigned by management
• Support Pharmacovigilance with various ad hoc deliverables or projects as needed
• Collaborate with cross-functional teams to ensure seamless execution of safety and pharmacovigilance activities

What We Are Looking For

• Degree in Pharmacy (PharmD) or Nursing (RN)
• Minimum of 2 years of experience working in the pharmaceutical industry, preferably in a Pharmacovigilance Department
• Demonstrated understanding of the assessment and processing of safety reports, including regulatory reporting obligations
• Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA
• Excellent computer skills in MS Word, PowerPoint, and Excel
• Strong facilitation, organizational, analytical, and time management skills
• Ability to work in a fast-paced environment and adapt to changing priorities
• Excellent communication and interpersonal skills
• Team-oriented with a strong sense of accountability

Nice to Have

• Experience with other pharmacovigilance databases or systems
• Knowledge of regulatory requirements and guidelines for pharmacovigilance
• Certification in pharmacovigilance or a related field
• Experience working in a remote or virtual team environment

Benefits and Perks

• Competitive salary
• Comprehensive healthcare benefits
• Life insurance and disability benefits
• Profit sharing and 401k matching
• Paid time off and holidays
• Remote work stipend and support for home office setup
• Opportunities for professional development and growth
• Collaborative and dynamic work environment
• Recognition and reward programs for outstanding performance

• Tip: Develop a strong understanding of pharmacovigilance regulations and guidelines, including those related to adverse event reporting and safety data management.
• Be prepared to provide specific examples of your experience with pharmacovigilance databases and systems, such as ARGUS and MedDRA.
• Highlight your analytical and problem-solving skills, as well as your ability to work in a fast-paced environment with multiple priorities.
• Consider obtaining certification in pharmacovigilance or a related field to demonstrate your expertise and commitment to the field.
• Research the company's culture and values to ensure alignment with your own goals and expectations.
• Prepare to discuss your experience with quality checks and reconciliations of safety data, as well as your ability to maintain corporate compliance and adhere to regulatory requirements.