Sr. Pharmacovigilance (PV) Clinical Scientist

The Fountain Group LLC

South San Francisco, CA
8 days ago

Highlights

PV Clinical Scientist leads clinical review of US Government Client cases (processed in-house or externally by the vendor) and supports the US Patient Safety PV Clinical Associate Group Director and PV Clinical Group Director-PV Compliance Team in all activities. Acts as single point of contact with key stakeholders for safety-related activities, identifies potential business gaps, and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Patient Safety PV Clinical management.

Numbers & Facts

Location	South San Francisco, CA
Industry	Staffing/Employment Agencies
Company Size	500 to 999 employees
Website	https://www.thefountaingroup.com/

Description

Details for the position are as follows:

Rate: $62.94
6.5-month contract to start
Location: South San Francisco, CA -Hybrid 4 days onsite

Job Description:

The US Patient Safety Sr. PV Clinical Scientist - Pharmacovigilance (PV) Compliance Team performs the tactical and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Patient Safety. The Sr. PV Clinical Scientist leads clinical review of US Government Client cases (processed in-house or externally by the vendor) and supports the US Patient Safety PV Clinical Associate Group Director and PV Clinical Group Director-PV Compliance Team in all activities. All responsibilities are performed under the direction of the US Patient Safety PV Clinical Management. Contributes in depth knowledge of Individual Case Safety Reports (ICSRs) case processing. Has developed a variety of skills typically gained through years of professional experience. Works autonomously with minimal supervision. May lead or contribute with skills to projects. May act as coach for colleagues with less experience and provide guidance.
Completes 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) Reviews, evaluates, and verifies potential AE information during triage 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. Performs seriousness / validity/causality and conducts quality review of all cases (as applicable) based on their medical assessment
Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable)
Responsible for leading efforts to ensure quality of Individual Case Safety Reports (ICSRs) is at par with company standards
Responsible for maintaining thorough knowledge of ICSR requirements for assigned Therapeutic Areas (TA)
Performs trend analysis of vendor case processing issues for assigned TA and escalates to vendor, TA Leads and US Government Client management as applicable
Update and create SOPs; lead process improvement initiatives
Responsible for developing executive summary on the quality trends observed on a quarterly basis
Ensures quality of Health Authority (HA) submissions is at par with local regulations
Responsible for Clinical Review of cases processed in-house and by vendors
Understands case processing data to evaluate error rates and potential compliance impact
Responsible for training internal US Government Client and/or vendors staff or team and ensure PV compliance
Collaborate with departments and partners on drug safety data exchange
Responsible for ensuring appropriate data correction in the safety database for identified issues or errors
Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Compliance Team Scientist /Vendor staff via the correspondence module
Accountable for training internal and external staff members on using correspondence module Performs reconciliation of outgoing communications
Maintains robust knowledge of Technical Product Complaints (TPC) & Medical Product Complaint (MPC) for all company products including combination products
Responsible for ensuring all product complaints are reported to the appropriate stakeholders within defined timelines
Ensures appropriate due diligence to obtain missing and/or additional information for Adverse Events (AEs) is performed in accordance with company SOPs / local and global regulations
Escalates any issues pertaining to follow up activities and provide strategic resolution to US Government Client management
Assists US Government Client management in maintaining oversight for GVP vendors
Identifies the risks and gaps pertaining to case processing for GVP Vendors
Continuously monitors feedback to inform quality improvements and updates
Responsible for performing impact assessment for any new / updated company SOPs or Health Authority requirements pertaining to ICSR processing and implements any process changes required based on the identified impact
Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
Acts as single point of contact with key stakeholders for safety-related activities, identifies potential business gaps, and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Patient Safety PV Clinical management
Responsible for the preparation and development of Patient Safety presentations and participates in the education offer internal /external stakeholders/vendors as applicable
Acts as Subject Matter Expert (SME) for safety-related activities within Global Safety Database per Genentech/Roche SOPs

Required Skills:

Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD)
Minimum 5 - 7 years of experience in a biopharma company with Pharmacovigilance responsibilities (Preferred); OR equivalent clinical experience with thorough understanding
Must have end to end ICSR case processing experience

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About Company

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.