Sr. Pharmacovigilance (PV) Clinical Scientist

Apollopros; South San Francisco (CA); Hybride; USD 130 000 - 190 000; Plein temps

Résumé du poste

Apollopros in South San Francisco, CA, seeks a Senior Pharmacovigilance Clinical Scientist on a hybrid contract basis to lead clinical review activities and ensure high-quality safety data processing in line with FDA/ICH/EMA requirements.

You will oversee case processing, QA/compliance, vendor oversight, and cross-functional safety collaborations, providing SME guidance in a fast-paced biopharma setting.

Qualifications

• 5-7+ years of pharmacovigilance experience in biopharmaceutical/healthcare environments.
• In-depth knowledge of AE reporting (ICSRs), FDA/EMA/ICH guidelines, and pharmacovigilance requirements.
• Experience in medical writing, data entry, and safety system usage.
• Project management, leadership, and ability to work cross-functionally in a regulated setting.

Responsabilités

• Perform clinical review, triage AE seriousness, causality, and medical review of cases.
• Ensure accurate safety data entry and timely ICSR processing in global safety databases.
• Lead data quality, compliance oversight, and trend analysis for vendor case processing.
• Train teams and external vendors; support audits, inspections, and safety initiatives.

Formation

Healthcare Professional degree (RN/BSN/MSN or equivalent)

Description du poste

Senior Pharmacovigilance (PV) Clinical Scientist

Location: South San Francisco, CA (Hybrid)

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

Interview Process: Two Rounds (30-minute Hiring Manager Interview + 30-minute Leadership Interview)

About the Opportunity

Our client is seeking an experienced Senior Pharmacovigilance (PV) Clinical Scientist to join its Patient Safety and PV Compliance team. This high-impact contract role is ideal for a safety professional with deep expertise in pharmacovigilance, adverse event case processing, Individual Case Safety Reports (ICSRs), drug safety compliance, and regulatory reporting. In this position, you will lead clinical review activities, oversee case quality and compliance, support vendor oversight, and partner with cross-functional stakeholders to ensure patient safety standards are maintained across the organization. The successful candidate will bring strong scientific judgment, regulatory knowledge, and the ability to work independently in a fast-paced biopharmaceutical environment.

Key Responsibilities

• Pharmacovigilance & Case Management Perform clinical review, evaluation, and processing of adverse event (AE) reports. Conduct triage assessments, including seriousness, validity, causality, and medical review of cases. Complete accurate and timely safety data entry and case processing within the global safety database. Perform labeling assessments and follow-up activities for reported adverse events. Ensure high-quality ICSR processing in accordance with company procedures, FDA regulations, ICH guidelines, EMA requirements, and global pharmacovigilance standards. Support AE reconciliation and Case Transmission Verification (CTV) activities as applicable.


• Quality & Compliance Oversight Lead initiatives to ensure the quality and compliance of ICSR processing in accordance with company procedures, FDA regulations, ICH guidelines, EMA requirements, and global pharmacovigilance standards. Monitor case processing metrics, evaluate error trends, and assess potential compliance impacts. Conduct trend analysis of vendor case processing issues and elevate findings as appropriate. Ensure timely correction of identified data quality issues within safety systems. Perform impact assessments for new or revised SOPs and regulatory requirements, implementing necessary process updates.


• Process Improvement & Vendor Management Create, update, and maintain SOPs, training materials, and operational procedures. Lead process improvement initiatives that enhance PV compliance and operational efficiency. Assist with oversight of pharmacovigilance vendors, identifying risks, gaps, and improvement opportunities. Monitor follow-up activities and correspondence processes to ensure regulatory compliance.


• Training, Leadership & Collaboration Train and mentor internal teams and external vendors on PV processes, compliance requirements, and safety systems. Serve as a Subject Matter Expert (SME) for safety-related activities and global safety database processes. Develop executive summaries and quarterly quality trend reports for leadership review. Partner with cross-functional departments on safety data exchange and patient safety initiatives. Act as a key point of contact for safety-related projects and stakeholder communications. Support audits, inspections, presentations, and educational initiatives for internal and external audiences.

Qualifications

• Required Education Healthcare Professional degree, such as: RN, BSN, MSN Nurse Practitioner (NP) RPh, B.Pharm, PharmD MD


• Required Experience 5-7+ years of pharmacovigilance experience within a biopharmaceutical, pharmaceutical, or related healthcare environment; or equivalent clinical experience with strong drug safety expertise. In-depth knowledge of: Adverse Event (AE) reporting Individual Case Safety Reports (ICSRs) FDA safety regulations and submissions ICH guidelines EMA regulations Global pharmacovigilance requirements Experience with scientific or medical writing. Strong computer proficiency and data entry experience. Project management experience.


• Preferred Skills & Competencies Strong medical and scientific assessment capabilities. Proven leadership, coaching, and mentoring experience. Excellent decision-making and problem-solving skills. Ability to analyze complex safety data and compliance issues. Strong communication, presentation, and stakeholder management skills. Exceptional attention to detail and ability to meet deadlines. Experience working with internal and external partners in a highly regulated environment. Ability to thrive in a fast-paced, evolving organization. Willingness to travel domestically and internationally as business needs require.

Why This Role?

This is an excellent opportunity for a seasoned Pharmacovigilance Clinical Scientist to play a critical role in drug safety, patient safety compliance, ICSR quality oversight, regulatory reporting, and pharmacovigilance operations while partnering with industry-leading professionals in a collaborative and innovative environment.