Pharmacovigilance Specialist

Pharmacovigilance Specialist 2.8 2.8 out of 5 stars Rancho Cucamonga, CA 91730 $110,000 - $140,000 a year - Full-time Amphastar Pharmaceuticals Inc. 104 reviews $110,000 - $140,000 a year - Full-time Amphastar Pharmaceuticals is seeking an experienced Pharmacovigilance professional to support and oversee global drug safety activities for marketed and investigational products. The successful candidate will be responsible for adverse event case management, safety surveillance, signal detection, regulatory compliance, and cross-functional collaboration with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams. This position plays a critical role in ensuring patient safety, maintaining compliance with global pharmacovigilance regulations, and supporting the continued growth of Amphastar's product portfolio. Essential Responsibilities Manage and oversee pharmacovigilance activities for assigned marketed and development-stage products. Review, evaluate, and process adverse event reports in accordance with FDA, ICH, and global regulatory requirements. Perform medical and scientific assessment of safety data, including causality and seriousness determinations. Support signal detection, risk assessment, and benefit-risk evaluations. Contribute to the preparation and review of aggregate safety reports, including PBRERs, PSURs, DSURs, and annual reports. Collaborate with Clinical Research, Regulatory Affairs, Medical Affairs, and Quality Assurance to ensure compliance with pharmacovigilance obligations. Support health authority inspections, audits, and pharmacovigilance system assessments. Assist in the development and maintenance of SOPs, work instructions, and pharmacovigilance processes. Monitor compliance metrics and support continuous improvement initiatives within the safety function. Provide training and guidance to internal stakeholders regarding pharmacovigilance requirements and reporting obligations. Participate in vendor oversight activities for contract pharmacovigilance service providers. Qualifications Bachelor's degree in Nursing, Pharmacy, Public Health, Life Sciences, Medicine, or a related scientific discipline. Minimum 5 years of pharmacovigilance, drug safety, clinical research, or related pharmaceutical industry experience. Strong understanding of FDA, ICH, GVP, and global pharmacovigilance regulations. Experience with adverse event case processing and safety database systems. Excellent analytical, organizational, and communication skills. Ability to work independently and collaboratively in a fast-paced environment. Preferred Qualifications MPH, MS, PharmD, MD, PA, NP, RN, or other advanced clinical/scientific degree. Experience supporting both commercial products and clinical development programs. Experience preparing aggregate safety reports and safety narratives. Prior experience participating in regulatory inspections and audits. Knowledge of signal detection and risk management activities. Leadership Expectations (Senior Manager Level) Lead pharmacovigilance projects and process improvement initiatives. Serve as a subject matter expert for drug safety and regulatory compliance. Mentor junior staff and support departmental development. Drive operational excellence and inspection readiness. Sunshine Act Amphastar reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Amphastar to provide government agencies with information such as a health care provider's name, address, and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Amphastar intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Amphastar that we pay or reimburse, your name, address, and the number of payments made currently will be reported to the government. EEO & Employment Eligibility Amphastar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Amphastar also complies with all applicable federal, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Amphastar is an E-Verify employer. Amphastar is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Job Type:

Full-time Pay:

$110,000.00 - $140,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Referral program Retirement plan

Education:

Bachelor's (Required)

Experience:

pharmacovigilance, drug safety, clinical research, or pharma: 5 years (Preferred)

Work Location:

In person