US Patient Safety, PV Clinical Scientist

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The US Patient Safety, PV Clinical Scientist sits within our Pharmacovigilance (PV) System Process and Oversight team and performs various tactical and operational job 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. In addition, 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:

• You will complete drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/Roche Standard Operating Procedures(SOPs)

• You will review, evaluate, and verify potential AE information to determine required action per internal policies and procedures and perform data entry of adverse events by timely completion of the case via Roche global safety database.

• You will perform seriousness/validity/causality and conduct quality review of all cases (as applicable) based on medical assessment

• You will perform labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable)

• You will be responsible for Clinical Review of cases processed in-house and by vendors

• You understand case processing data to evaluate error rates and potential compliance impact; you will perform trend analysis of vendor case processing issues and escalates to vendor and USPS management

• You will be responsible for developing summary on the quality trends observed on a quarterly basis

• You will be responsible for training internal USPS and/or vendors staff or team

• You will be responsible for ensuring appropriate data correction in the safety database for identified issues or errors

• You will be responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Systems Process and Oversight Scientist /Vendor staff via the correspondence module

• You will be accountable for training internal and external staff members on using communication module; Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)

• You will perform reconciliation of outgoing communications; you will be responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners

• You will assist in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)

• You will act as point of contact with key stakeholders for safety-related activities, identify potential business gaps and assist in the development and implementation of process solutions, and lead projects as assigned and under the direction of the US Patient Safety management

• You will be responsible for the preparation and development of Patient Safety presentations and participate in the education offer internal /external stakeholders as applicable

• You will act as Subject Matter Expert (SME) for safety-related activities within Global Safety Database per Genentech/Roche SOPs

• You will provide support during audits and inspections

• You will collaborate with other teams as needed; you have the ability to travel as per business needs

This is a US Based remote position.
Relocation benefits are not being offered.

Who You Are:

(Required)

• You have a Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD) with 2+ years of clinical experience

• You have a demonstrated level of proficiency in science/medical writing

• You have demonstrated level of proficiency to comprehend medical information

• You have demonstrated computer proficiency and data entry experience; you have demonstrated ability to anticipate and solve problems; effectively make decisions of moderate complexity and scope (e.g., evaluate, interpret and present highly complex data)

Preferred:

• You have demonstrated project management experience

• You have demonstrated safety assessment experience

• You have experience working with health authorities on safety related matters

• You have the ability to collaborate with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such

• You have strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: has built and cultivated important relationships both inside an organization and externally. Has proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties. Seamlessly collaborates with colleagues/other parts of the organization.

The expected salary range for this position based on the primary location of South San Francisco, CA is $98,000 - $182,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.