US Patient Safety, PV Clinical Scientist

Genentech; Los Angeles (CA); Remote; USD 98,000 - 183,000; Full time

Job summary

An innovative company is seeking a dedicated PV Clinical Scientist to join their dynamic Pharmacovigilance team. In this remote role, you will play a crucial part in ensuring patient safety by performing clinical reviews, evaluating adverse event data, and collaborating with various stakeholders. Your expertise in scientific writing and clinical experience will be essential as you navigate complex data and contribute to safety assessments. This position offers a competitive salary and the opportunity to make a significant impact in the field of patient safety. If you are passionate about advancing healthcare and have a strong background in clinical science, we encourage you to apply.

Qualifications

• At least 2 years of clinical experience in a healthcare role.
• Proficient in scientific/medical writing and data interpretation.

Responsibilities

• Complete drug safety monitoring and tracking according to PV standards.
• Review and evaluate potential adverse event information.

Skills

Scientific/Medical Writing

Data Entry

Problem-Solving

Interpersonal Communication

Clinical Experience

Education

Healthcare Professional Degree (RN/BSN/MSN/NP/RPh/B Pharm/Pharm D/MD)

Tools

Global Safety Database

Job description

The Position

We advance science so that we all have more time with the people we love.

The US Patient Safety, PV Clinical Scientist sits within our Pharmacovigilance (PV) System Process and Oversight team and performs various tactical and operational responsibilities. This includes but is not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Patient Safety. The PV Clinical Scientist conducts clinical review of USPS cases (processed in-house or externally by the vendor) and contributes strong knowledge of Individual Case Safety Reports (ICSRs) case processing. The PV Clinical Scientist supports the US Patient Safety PV Clinical Associate Group Director and PV Clinical Group Director, PV System Process and Oversight in all activities as required. All responsibilities are performed under the direction of the US Patient Safety PV Clinical Management.

Key Responsibilities:

1. You will complete drug safety monitoring and tracking in a timely, thorough, and accurate manner according to PV standards, regulations, and Genentech/Roche SOPs.
2. You will review, evaluate, and verify potential AE information to determine required actions per policies and perform data entry of adverse events in Roche's global safety database.
3. You will perform seriousness, validity, causality assessments, and conduct quality reviews of all cases as applicable based on medical assessment.
4. You will perform labeling assessments for received AEs using clinical knowledge and conduct follow-up for all reported cases as applicable.
5. You will be responsible for clinical review of cases processed in-house and by vendors.
6. You understand case processing data to evaluate error rates and potential compliance impact; you will perform trend analysis of vendor case processing issues and escalate as needed.
7. You will develop quarterly summaries of quality trends observed.
8. You will train internal USPS staff and/or vendors' staff or teams.
9. You will ensure appropriate data correction in the safety database for identified issues or errors.
10. You will maintain follow-up templates and ensure successful transmission of all follow-up attempts via the correspondence module.
11. You will train internal and external staff on communication modules and develop training documents such as SOPs as needed.
12. You will perform reconciliation of outgoing communications and negotiate/implement pharmacovigilance agreements with partners.
13. You will assist in AE reconciliation activities and case transmission verification as applicable.
14. You will serve as a point of contact with key stakeholders, identify business gaps, and assist in process development and project leadership under management guidance.
15. You will prepare and develop Patient Safety presentations and participate in educational activities for stakeholders.
16. You will act as Subject Matter Expert (SME) for safety activities within the Global Safety Database per SOPs.
17. You will support audits and inspections.
18. You will collaborate with other teams as needed and may travel based on business requirements.

This is a US-based remote position. Relocation benefits are not offered.

Who You Are:

Required:

• You have a healthcare professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD) with at least 2 years of clinical experience.
• You demonstrate proficiency in scientific/medical writing and comprehension of medical information.
• You have computer proficiency, data entry experience, and problem-solving skills, with the ability to evaluate and interpret complex data.

Preferred:

• Project management experience.
• Experience in safety assessment.
• Experience working with health authorities on safety matters.
• Strong interpersonal, verbal, and written communication skills; ability to influence and collaborate effectively with internal and external stakeholders.

The expected salary range for this position based on South San Francisco, CA location is $98,000 - $182,500. Actual pay will depend on experience, qualifications, location, and other factors. A discretionary bonus may be available.

This position qualifies for benefits detailed at the provided link.

Genentech is an equal opportunity employer. We promote and treat employees based on merit, qualifications, and competence, prohibiting unlawful discrimination. For accommodations related to the application process, please contact us via the provided form.