Top 81 Pharmacovigilance specialist Jobs

Pharmacovigilance Specialist
Amphastar Pharmaceuticals Inc. —Rancho Cucamonga, CA
- $110,000 - $140,000 a year
- Full-time
- Nursing
- Medicine
- Bachelor's degree
- Health savings account
- Health insurance
Quick Apply
9d
Pharmacovigilance Specialist
InfoQuest Consulting Group Inc. —Los Angeles, CA
- Email
- Nursing
- Mid-level
- Office
Pharmacovigilance Network Specialist
Vertex Pharmaceuticals —Boston, MA
- $82,400 - $123,600 a year
- Full-time
- Microsoft Excel
- Writing skills
- Research
- Loan repayment program
- Dental insurance
8d
Pharmacovigilance Specialist I, II, III
Gifthealth Inc —Columbus, OH
- $68,000 - $92,000 a year
- Full-time
- Hybrid work
- Nursing
- Mid-level
- Bachelor's degree
Quick Apply
8d
Senior Drug Safety and Pharmacovigilance Specialist
Travere Therapeutics —San Diego, CA
- $95,000 - $124,000 a year
- Weekends as needed
- Microsoft Excel
- Microsoft Outlook
- Office
- Health insurance
- Paid time off
Patient Access Liaison -Tepezza - New Orleans, Louisana
Amgen —New Orleans, LA
- $158,394 - $222,256 a year
- Weekends as needed
- Nursing
- Doctoral degree
- Up to 50% travel
- Disability insurance
- Health insurance
8d
Senior Specialist I, Postmarketing Patient Safety and Pharmacovigilance Operations
Corcept Therapeutics —Redwood City, CA
- $103,600 - $137,100 a year
- Mid-level
- 3 years
- Continuous improvement
Quick Apply
Pharmacovigilance and Regulatory Specialist
University of Colorado —Aurora, CO
- $68,994 - $115,911 a year
- Full-time
- Background check
- 3 years
- Bachelor's degree
- Disability insurance
- Health insurance
9d
Patient Access Liaison - Rare Disease - Central
Amgen —Chicago, IL
- $158,394 - $222,256 a year
- Weekends as needed
- Doctoral degree
- Up to 50% travel
- HIPAA
- Disability insurance
- Health insurance
Patient Access Liaison - Rare Disease - East
Amgen —New York, NY
- $158,394 - $222,256 a year
- Weekends as needed
- Doctoral degree
- Up to 50% travel
- HIPAA
- Disability insurance
- Health insurance
Patient Access Liaison - Rare Disease - US Field (West)
Amgen —Los Angeles, CA
- $158,394 - $222,256 a year
- Weekends as needed
- Doctoral degree
- Up to 50% travel
- HIPAA
- Disability insurance
- Health insurance
Patient Access Liaison – UPLIZNA IgG4-RD (Central)
Amgen —St. Louis, MO
- $158,394 - $222,256 a year
- Weekends as needed
- Nursing
- Doctoral degree
- Up to 50% travel
- Disability insurance
- Health insurance
Drug Safety Specialist III
Katalyst Healthcares & Life Sciences —Avenel, NJ
- Contract
- Nursing
- Management
- 5 years
Quick Apply
Business Capability Specialist
BioNTech AG —Cambridge, MA
- $113,600 - $181,600 a year
- Full-time
- Background check
- Computer Science
- 5 years
- Health savings account
- AD&D insurance
Specialist, DSPV Compliance
Insmed incorporated —New Jersey
- $42 - $53 an hour
- Full-time
- Remote
- Microsoft Excel
- Mid-level
- Bachelor's degree
- Employee stock purchase plan
- Disability insurance
Drug Safety Specialist I, II, III
Gifthealth Inc —Columbus, OH
- $23 - $31 an hour
- Full-time
- Hybrid work
- Nursing
- Mid-level
- High school diploma or GED
Quick Apply
Patient Access Liaison - TEPEZZA - Roanoke, VA
Amgen —Charleston, WV
- $158,394 - $222,256 a year
- Weekends as needed
- Nursing
- Doctoral degree
- Up to 50% travel
- Disability insurance
- Health insurance
8d
Senior Specialist, Quality Risk & Governance
Amgen —Municipio de Juncos, PR
- $132,037.30 - $178,638.70 a year
- Doctoral degree
- Master's degree
- High school diploma or GED
- Disability insurance
- Health insurance
Clinical Safety Specialist
4 C Medical Technologies —Maple Grove, MN
- $88,000 - $105,000 a year
- Full-time
- Nursing
- Microsoft Excel
- Mid-level
- Paid parental leave
- Paid holidays
PV Operations Specialist
SystImmune —Princeton, NJ
- $85,000 - $115,000 a year
- Full-time
- Nursing
- Mid-level
- Office
- Paid holidays
- Disability insurance

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Pharmacovigilance Specialist

Amphastar Pharmaceuticals Inc. -
Rancho Cucamonga, CA

Quick Apply

Job Details

Full-time
$110,000 - $140,000 a year
9 days ago

Benefits

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

Qualifications

Database systems
Adverse event reporting
Safety regulations
ICH guidelines
Bachelor's degree
Public Health
Clinical quality assurance standards
Patient safety and incident reporting systems
Legal compliance
FDA regulations

Full Job Description

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

Quick Apply

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pharmacovigilance specialist jobs

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