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Senior Pharmacovigilance (PV) Clinical Scientist
Pride Global
- 🇺🇸 United States
- Hybrid
- Senior
- 6 days ago
- Regulatory Compliance
- ICH
- PharmD
- LPN
- Pension
6 days ago
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Responsibilities:
- Conduct clinical review and quality assessment of ICSRs and adverse event cases processed internally and by vendors.
- Ensure accurate case processing and compliance with FDA, ICH, EMA, global PV regulations, and company SOPs.
- Monitor case quality trends, identify vendor errors, assess compliance risks, and prepare quality reports.
- Lead SOP updates, process improvements, regulatory impact assessments, and PV compliance initiatives.
- Oversee adverse event follow-ups, safety database corrections, reconciliation, and regulatory submission quality.
- Develop training materials, guide internal teams and vendors, support audits and inspections, and lead assigned projects.
Requirements:
- Healthcare professional degree required (RN/BSN/MSN, NP, RPh, BPharm, PharmD, or MD).
- 5–7 years of pharmacovigilance experience preferred, or equivalent clinical experience with strong PV regulatory knowledge.
- Strong knowledge of ICSR processing, clinical case review, FDA/ICH/EMA regulations, and global PV requirements.
- Experience in medical/scientific writing, SOPs, quality reporting, and safety database operations.
- Project management experience with strong analytical, clinical judgment, and problem-solving skills.
- Excellent communication, leadership, stakeholder management, and attention to detail.
Additional Details:
- Location model: South San Francisco CA (Hybrid)
- Shift: Mon to Fri 8am to 4:30pm PST
- Position Type: 06-month contract (potential to extend)
- Pay range approved: $50/hr - $63.82/hr (depending on experience)
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Russell Tobin is a professional recruitment and staffing advisory firm that connects job seekers and employers across various industries. We are a staffing arm of Pride Global. Affiliates include Russell Tobin, Pride health, Pride Now and Pride One.
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For workers in the United States, PrideGlobal and it's affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.
Equal Employment Opportunity
PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.
Fair Chance Employment
PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.
Accommodations
We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.
Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.
Only applicable for Kentucky positions: For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.
Senior Pharmacovigilance (PV) Clinical Scientist · Pride Global