Sr. Pharmacovigilance (PV) Clinical Scientist

Pride Health is hiring a Sr PV Clinical Scientist for a client located in South San Francisco, CA!

Location: Hybrid, South San Francsico, CA

Schedule: Monday through Friday (8 AM to 4:30 PM PT)

Type: 6 month contract

Pay Rate: 50-63/hr

Job Duties:

• Conducts drug safety monitoring and adverse event (AE) case processing, including triage, data entry, assessments, labeling review, follow-up, and quality review in compliance with PV regulations and Genentech/Roche SOPs.
• Ensures quality and regulatory compliance of ICSRs, Health Authority submissions, and safety database data.
• Performs clinical review of cases, trend analysis, error assessment, vendor oversight, and implements corrective actions and process improvements.
• Develops, updates, and assesses SOPs, training materials, and process changes related to safety reporting requirements.
• Trains internal and vendor staff, maintains correspondence processes, and monitors PV compliance.
• Oversees product complaint reporting (TPC/MPC), AE follow-up activities, reconciliation, and Case Transmission Verification (CTV) as applicable.
• Serves as SME and primary contact for safety-related activities, supports audits and inspections, prepares presentations, leads projects, and collaborates with stakeholders and patient safety teams.

Qualifications:

• Health Care Background (RN/BSN/MSN, NP, RPh/B, Pharm/PharmD
• Minimum 5 - 7 years of experience in a biopharma company with Pharmacovigilance responsibilities (Preferred)
• Thorough understanding of FDA safety regulations, ICH guidelines, and other applicable regulatory guidance documents, global PV regulatory environment, EMA regulations
• Writing experience; science/medical writing (Required)
• Computer proficiency and Data entry experience (Required)
• Project Management (Required)

Apply for this role with Pride Health!

Pride-Health 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

Pride-Health is 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

Pride-Health is 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.

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