Sr. Pharmacovigilance (PV) Clinical Scientist - 30777

Job Description

Job Description

Senior Pharmacovigilance Scientist

Location: South San Francisco, CA (Hybrid)

Employment Type: Contract | Full-Time

Pay Rate: $55.94- $62.94

Schedule: Monday – Friday | 8:00 AM – 4:30 PM PT

Role Overview

BEPC Inc. is seeking an experienced Senior Pharmacovigilance Scientist to support our client's US Patient Safety team in South San Francisco, CA.

This position offers an exciting opportunity to contribute to patient safety, drug safety monitoring, and regulatory compliance within a leading biopharmaceutical environment.

The ideal candidate will have extensive experience in pharmacovigilance (PV), Individual Case Safety Report (ICSR) processing, adverse event (AE) assessment, and Good Pharmacovigilance Practices (GVP).

In this role, you will lead clinical safety case reviews, oversee vendor case processing quality, evaluate regulatory compliance, and drive continuous improvement initiatives. You will also collaborate with cross-functional teams to ensure accurate, timely, and compliant safety reporting.

This is an excellent opportunity for a highly skilled pharmacovigilance professional who thrives in a collaborative environment and is passionate about advancing patient safety.

Key Responsibilities

Pharmacovigilance & Drug Safety

• Lead the clinical review, evaluation, and processing of adverse event (AE) reports and Individual Case Safety Reports (ICSRs).
• Assess adverse events for seriousness, validity, causality, and expectedness in accordance with applicable regulatory requirements.
• Perform medical and clinical assessments of safety cases, including labeling evaluations and follow-up activities.
• Ensure accurate and timely entry, processing, and maintenance of safety information within the global safety database.
• Maintain comprehensive knowledge of ICSR processing requirements across assigned therapeutic areas.
• Ensure compliance with FDA regulations, EMA requirements, ICH guidelines, and internal Standard Operating Procedures (SOPs).

Quality Assurance & Regulatory Compliance

• Lead quality reviews of safety cases processed internally and by external pharmacovigilance vendors.
• Monitor case processing accuracy, identify trends, and evaluate potential regulatory compliance risks.
• Conduct trend analyses of vendor case processing errors and recommend corrective actions.
• Develop quarterly executive summaries highlighting safety case quality trends, compliance risks, and improvement opportunities.
• Ensure Health Authority submissions meet applicable regulatory requirements and quality standards.
• Support pharmacovigilance audits and regulatory inspections.
• Assess the impact of new or updated regulatory requirements and SOPs on ICSR processing activities.

Vendor Oversight & Process Improvement

• Support oversight of external Good Pharmacovigilance Practices (GVP) vendors.
• Identify operational gaps, compliance risks, and opportunities to improve vendor performance.
• Lead process improvement initiatives to enhance pharmacovigilance efficiency and reporting accuracy.
• Develop, revise, and implement SOPs, training materials, and standardized processes.
• Provide training and guidance to internal patient safety teams and external vendors.
• Collaborate with stakeholders to implement corrective actions and improve case processing quality.

Safety Database Management & Reporting

• Serve as a Subject Matter Expert (SME) for safety-related activities within the global safety database.
• Identify and resolve safety database discrepancies, ensuring appropriate data corrections.
• Maintain adverse event follow-up templates and oversee communications through the safety database correspondence module.
• Train internal and external personnel on correspondence module functionality and procedures.
• Perform reconciliation of outgoing safety communications and support Case Transmission Verification (CTV) activities.
• Ensure appropriate follow-up activities are completed to obtain missing or additional adverse event information.
• Monitor safety case data to identify error rates, reporting trends, and potential compliance concerns.

Cross-Functional Collaboration & Leadership

• Partner with internal patient safety teams, external vendors, and cross-functional stakeholders to ensure effective drug safety information exchange.
• Coordinate the reporting of Technical Product Complaints (TPCs) and Medical Product Complaints (MPCs), including those involving combination products.
• Ensure product complaints are communicated to appropriate stakeholders within required timelines.
• Lead assigned pharmacovigilance projects and support strategic patient safety initiatives.
• Develop and deliver presentations, training sessions, and educational materials for internal and external stakeholders.
• Provide guidance and mentorship to less experienced team members.
• Support management in identifying operational risks and implementing effective solutions.

Qualifications

Required Qualifications

• Education: Healthcare Professional degree required, such as:
• • Registered Nurse (RN), Bachelor of Science in Nursing (BSN), or Master of Science in Nursing (MSN).
  • Nurse Practitioner (NP).
  • Registered Pharmacist (RPh), Bachelor of Pharmacy (BPharm), or Doctor of Pharmacy (PharmD).
  • Medical Doctor (MD).
• Professional experience in pharmacovigilance within a biopharmaceutical environment or equivalent clinical experience.
• Thorough understanding of FDA safety regulations, ICH guidelines, EMA regulations, and global pharmacovigilance requirements .
• Strong knowledge of adverse event reporting, ICSR processing, and drug safety compliance.
• Experience performing clinical safety case reviews and evaluating adverse event information.
• Scientific or medical writing experience.
• Strong computer proficiency, including data entry and documentation.
• Demonstrated project management experience.
• Excellent written and verbal communication skills.
• Strong analytical skills, attention to detail, and ability to manage complex safety-related information.
• Ability to work independently, exercise sound judgment, and manage competing priorities.
• Strong collaboration skills and experience working with cross-functional teams.

Preferred Qualifications

• 5–7 years of pharmacovigilance experience within a biopharmaceutical company.
• Experience conducting clinical reviews of Individual Case Safety Reports (ICSRs).
• Experience with global safety databases and adverse event reporting systems.
• Knowledge of Good Pharmacovigilance Practices (GVP) and vendor oversight.
• Experience supporting pharmacovigilance audits, inspections, and regulatory submissions.
• Experience developing SOPs, conducting training, and implementing process improvements.
• Experience performing quality trend analysis and identifying regulatory compliance risks.
• Demonstrated leadership experience, including mentoring colleagues and coordinating cross-functional initiatives.

Key Competencies

• Strong clinical judgment and ability to interpret complex medical information.
• Excellent organizational skills and attention to detail.
• Proven ability to identify compliance risks and develop effective solutions.
• Strong leadership, communication, and presentation skills.
• Ability to work autonomously while collaborating effectively with internal and external stakeholders.
• Strong problem-solving and decision-making capabilities.
• Ability to adapt to changing priorities in a fast-paced, regulated environment.
• Willingness to travel domestically or internationally as business needs require.

Contract Details

Position: Senior Pharmacovigilance Scientist

Location: South San Francisco, CA

Work Arrangement: Hybrid (On-site and Remote)

Employment Type: Full-Time Contract

Work Schedule: Monday – Friday, 8:00 AM – 4:30 PM PT

Interview Process: Two rounds

• Round 1: Hiring Manager Interview (30 minutes)
• Round 2: Upper Management Interview (30 minutes)

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management.

At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive.

With competitive benefits, including medical, dental, vision, and life insurance , BEPC is dedicated to supporting our employees' personal and professional growth.

As an employee-owned company through our Employee Stock Ownership Program (ESOP), we believe in creating opportunities for our team members to contribute to our shared success.

Apply Now!

Are you an experienced Senior Pharmacovigilance Scientist looking to make a meaningful impact on patient safety and regulatory compliance?

BEPC Inc. invites you to apply and contribute your expertise to an exciting opportunity within the biopharmaceutical industry.

To be considered, please submit an up-to-date resume that clearly demonstrates your relevant qualifications and experience.

Your resume should include specific examples of your experience with:

• Pharmacovigilance and drug safety monitoring.
• Individual Case Safety Report (ICSR) processing and clinical review.
• FDA, EMA, and ICH regulatory compliance.
• Adverse event assessment and safety database management.
• Vendor oversight, quality assurance, and process improvement.
• Medical or scientific writing and project management.

We look forward to reviewing your application!

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive.

With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

Company Description

About BEPC\n\nBEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive.\n\nWith competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.