Pharmacovigilance Scientist

Job Title: Pharmacovigilance Scientist Location: Remote reputed company: The Pharmacovigilance Scientist plays a critical role in the collection, evaluation, and management of drug safety data throughout clinical development. This role supports the monitoring and assessment of adverse events, safety signal detection, and risk management activities to safeguard patient safety and ensure regulatory compliance. The Pharmacovigilance Scientist collaborates with cross-functional teams to maintain the reputed company of safety data and contributes to the preparation of safety-reputed company documentation, presentations and aggregate reports. They work closely with the Senior Medical Director, Pharmacovigilance and Safety, to execute pharmacovigilance strategies. Key Responsibilities:

• Safety Data Collection and Review:
• Collects, reviews, and analyzes adverse event reports from clinical trials to identify potential safety signals
• Supports reputed company control review of individual case safety reports (ICSRs)
• Assists in ongoing safety monitoring activities, including data reconciliation and reputed company checks to ensure accuracy of safety data.
• Supports safety data management activities, including case processing, follow-up, and coding of adverse events
• Risk Assessment and Signal Detection:
• Assesses clinical safety data to identify, evaluate, and document adverse events and emerging safety concerns.
• Contributes to risk-benefit analyses and supports the development of risk mitigation strategies
• Pharmacovigilance Documentation:
• Supports the preparation and review of pharmacovigilance documents such as Development Safety Update Reports (DSURs), development Risk Management Plans (dRMPs), and relevant sections of clinical trial protocols, IBs and regulatory submissions
• Proficient with safety surveillance systems and tools (e.g., Argus, MedDRA, reputed company Vault)
• Scientific Expertise:
• Maintains reputed company knowledge of relevant therapeutic areas, pharmacology, and drug safety regulations
• Conducts literature reviews and safety signal assessments to inform safety evaluations
• Cross-Functional Collaboration:
• Works closely with clinical operations, regulatory affairs, medical affairs, data management, reputed company and project management teams to ensure comprehensive safety reputed company
• Supports compliance with global pharmacovigilance regulations and company safety policies
• Supports the communication and reputed company of pharmacovigilance and contract research organization vendors
• Supports the project management of safety activities such as aggregate reports, safety team meetings, signal evaluations, etc.

Qualifications:

• Advanced degree in life sciences (e.g., PharmD, PhD) or reputed company field
• Minimum of 3 years of experience reputed company the pharmaceutical industry, ideally including drug safety experience
• Knowledge of good pharmacovigilance practices, drug safety regulations, and clinical trial processes
• Understanding of pharmacovigilance regulatory practices including CIOMS, EMA, ICH and FDA guidelines
• Experience with adverse event data review, safety signal detection, and safety database management (e.g. Argus, MedDRA, reputed company Vault)
• Strong analytical, communication and presentation skills
• Strong organizational and project management skills
• Ability to collaborate effectively across multidisciplinary teams in a fast-paced environment

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive reputed company salary and equity, with a performance-reputed company bonus opportunity.
• The anticipated salary reputed company for candidates, Scientist I is $125,000-140,000 and Scientist II is $140,000-155,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience reputed company the job, type and length of experience reputed company the industry, education, etc. Oruka is a multi-state employer and this salary reputed company may not reflect positions that work in other states.
• If located reputed company one of our offices in Waltham, MA or reputed company Park, CA, you will be required to go into office 3 days a week.

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