Clinical Pharmacovigilance Scientist
Location: New York - Remote
Salary: $110,000- $150,000
A clinical-stage biopharmaceutical company specializing in immunotherapies is seeking a Clinical PV scientist. The company creates unique therapies that targets multiple cancers including Pancreatic, lung, prostate and many others. They are also developing treatments for autoimmune diseases.
The Clinical Pharmacovigilance Scientist will work in tandem with the PV Physician to monitor and identify safety events as well work on the risk benefit profile during clinical trials.
Main Responsibilities:
- Engaged in the collection, examination, interpretation, and analysis of safety-related data to produce insights that aid safety-related decision-making and reporting. Your role involves applying your expertise in pharmacovigilance, oncology, and scientific knowledge to manage all aspects of safety documentation, including creating or providing strategic safety input for regulatory documents such as regulatory reports, responses to health authorities, and the safety content within marketing authorization applications.
- Identification and assessment of signals
- Providing support for proactive safety monitoring and risk management for designated clinical studies
- Conducting independent assessments of safety data
- Collaborating with Pharmacovigilance physicians and Study Teams to assess Informed Consent Forms (ICFs), Clinical Study Reports, Safety Monitoring Plans, and statistical data intended for aggregate review and the preparation of DSURs
- Drafting relevant sections of Investigator's Brochures (IB) and comprehensive safety reports
- Contributing to responses to regulatory authorities' inquiries related to assigned studies, as required
- Organizing safety meetings and maintaining meeting minutes
Qualifications & Skills:
- A bachelor's degree in a scientific, pharmaceutical, nursing, or related field, coupled with at least three years of experience in the field of pharmacovigilance.
- Experience in drug development encompassing both early and late phases, including active identification and planning for risk mitigation.
- Preferred previous involvement in either oncology or vaccine-related projects.
- Interaction with governance boards and adeptness in cross-functional communication.
- Proficiency in the understanding of pharmacovigilance regulations.
- Demonstrated capacity to manage multiple concurrent activities effectively, with strong prioritization skills and an ability to discern critical issues.
- Possesses adaptability and flexibility, capable of responding to diverse demands and evolving priorities while maintaining professionalism and confidence.
- Skilled in working within an advanced matrix organizational structure, promoting cross-functional collaboration.
- Exceptional communication skills, both written and verbal, are mandatory.
- Proven ability to excel both as an independent worker and a team player.
- Strong emphasis on quality, coupled with excellent organizational skills.
- Proficient at handling multiple tasks and prioritizing effectively.
- Capable of synthesizing information and presenting it effectively.
- Exceptional decision-making and problem-solving abilities.
- Exhibits the capability to question decisions and challenge the existing status quo.
