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Manager of Pharmacovigilance and Safety Operations
2 months ago
Job Overview
At ZipRecruiter, we are dedicated to shaping remarkable futures by developing innovative solutions that enhance the lives of individuals and the landscape of healthcare.
Our team is composed of passionate, transparent, and impact-oriented professionals who believe in the power of uniqueness, determination, and authenticity to achieve our mission.
Position Type: Contract - 6 months - Hybrid
Role Summary: As a key member of the Global Drug Safety & Pharmacovigilance team, you will focus on safety operations, which encompass the collection and processing of safety information from diverse sources, ensuring quality control of safety data entry, regulatory submission of individual case safety reports (ICSRs), and case exchange with business partners.
Key Responsibilities:
- Conduct both real-time and retrospective quality control of safety case data entry to guarantee compliance with data entry conventions and MedDRA/WHO DD coding standards.
- Assist in managing the daily safety case workload, ensuring adherence to regulatory submission timelines and internal deadlines, including monitoring the workflow status of safety cases and pending regulatory submissions of ICSRs.
- Communicate effectively with safety vendors, safety physicians, and submission stakeholders as necessary.
- Provide expert guidance on inquiries related to Safety Operations, grounded in company standards as well as ICH and regulatory guidelines.
- Ensure accurate reporting destinations are populated for each safety case and approve regulatory reports for all applicable destinations in the safety database.
- Monitor and manage email communications received in Safety Operation Mailboxes.
- Review and contribute insights on individual study-specific documents, including but not limited to, Safety Operational Management Plans, SAE Reconciliation Plans, Data Validation Plans, and Safety Reporting Form Specifications Documents.
- Support the establishment and maintenance of individual study-specific activities.
- Perform reconciliations with internal and external stakeholders to ensure proper case exchanges as per relevant agreements.
- Analyze and provide explanations for any delays in the submission or distribution of safety reports, as applicable.
- Contribute to the development or revision of Standard Operating Procedures, Working Instructions, and training materials concerning safety case processing and operations.
- Participate in or support ZipRecruiter initiatives and projects on behalf of Safety Operations.
- Engage in additional activities as required or requested by your supervisor.
Qualifications:
We are seeking a Drug Safety professional with a minimum of 3 years of experience in drug safety and pharmacovigilance, including case quality control and regulatory submissions of ICSRs on a global scale.
A Bachelor's or Master's degree in a scientific discipline is required.
Essential knowledge includes:
- ICH E2B(R2) and (R3) specifications and entry guidance.
- Pharmacovigilance reporting regulations and timelines.
- Ability to interpret health and medical records, such as adverse event reporting forms and discharge summaries.
- Experience in clinical and/or post-marketing case processing, including MedDRA and WHO DD coding and narrative writing.
- Familiarity with safety databases; experience with Argus is advantageous but not mandatory.
- Experience with EDC for clinical trial data collection is a plus but not required.
- Strong attention to detail.
About You:
You are deeply passionate about our mission and genuinely care about transforming the lives of patients through innovative healthcare solutions.
You bring rigor and excellence to all your endeavors and are a strong advocate for our science-driven approach to problem-solving.
You thrive in collaborative environments, working effectively with diverse teams.
You are committed to doing your best and take pride in enabling the success of your colleagues.
You embrace challenges and are not afraid to innovate.
Experience in a fast-paced, dynamic organization is preferred, along with a strong work ethic and a sense of enjoyment in your work.
About ZipRecruiter:
Founded with a vision to innovate in the recruitment landscape, ZipRecruiter is committed to creating a diverse and inclusive workplace where all employees feel valued and empowered.
We believe that diversity is crucial for our success and strive to foster an environment where everyone can thrive.
Join us in our mission to connect talent with opportunity and make a meaningful impact in the world of work.
