Date Posted: 07/21/2026
Hiring Organization: Rose International
Position Number: 504507
Industry: Biotech/Healthcare
Job Title: Scientist
Job Location: South San Francisco, CA, USA, 94080
Work Model: Hybrid
Work Model Details: Working Model: Hybrid
Shift: 8 AM to 4:30 PM PT (mon - fri)
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 13
Min Hourly Rate($): 56.00
Max Hourly Rate($): 62.00
Must Have Skills/Attributes: Data Entry, Project Management, Regulatory
Experience Desired: Experience in a Biopharma company with Pharmacovigilance (5 yrs)
Required Minimum Education: Master’s Degree
Preferred Education: Ph.D / Doctorate
**C2C is not available**
Job Description
Education, Experience, and Other Requirements:
• Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD)
(Required)
• Minimum 5 - 7 years of experience in a biopharma company with Pharmacovigilance
responsibilities (Preferred); OR equivalent clinical experience with thorough understanding
of FDA safety regulations, ICH guidelines, and other applicable regulatory guidance
documents, global PV regulatory environment, EMA regulations (Required)
• Writing experience; science/medical writing (Required)
• Computer proficiency and Data entry experience (Required)
• Project Management (Required)
Key Accountabilities:
• Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Client 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 Client 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 USPS 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 USPS 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 USPS management
• Assists USPS 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 Client SOPs
• Provide support during audits and inspections
• Collaborates with other patient safety teams as needed
Competencies Identified for Success:
• Demonstrates capability to comprehend medical information
• Demonstrates ownership, initiative and accountability
• Sound decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility
• Demonstrates strong, dynamic leadership skills
• Works well independent or within teams and is effective in collaborating with others internally and externally Ability to exercise independent judgment and discretion in matters of significance
• Ability to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
• Ability to flex and thrive in an agile and fast-changing environment
• Strong attention-to-detail
• Strong attention-to-detail in establishing priorities and meeting deadlines
• Strong project management skills
• Ability to travel domestically and internationally as per business needs
- **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
Any time I did have a question and called, the phone was always answered, and my question/concern was immediately resolved.
Sally, Consultant
I have been very pleased with my experience with Rose International. Everyone that I encountered was very helpful and courteous.
Stephanie, Consultant
The interactions that I have had with your representatives have always been prompt and very professional. I am very pleased and impressed with your company and services.
Sioe, Consultant
It was great working for Rose International. Everyone was extremely helpful.
Rosann, Consultant
Rose is an assembly of people grounded in honesty, truth and dignity for all of its employees and contractors.
Samba, Consultant
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