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Senior Specialist in Medical Information

2 months ago

Denville, New Jersey, United States Ingenus Full time
Job Overview

As a Senior Specialist in Medical Information, you will play a pivotal role in supporting healthcare professionals, customers, and patients by managing medical inquiries and ensuring compliance with industry standards.

Key Responsibilities

· Provide expert telephone support to healthcare professionals, customers, and patients, addressing medical inquiries, adverse events, product quality concerns, and other necessary communications.

· Document and track incoming communications via telephone, fax, or email from various stakeholders during standard business hours.

· Foster effective communication within the team by offering regular updates to local management regarding project metrics, challenges, and achievements.

· Develop and maintain Standard Operating Procedures (SOPs) and Working Instructions to implement the Medical Information receipt system, ensuring adherence to regulatory requirements.

· Assess incoming reports for completeness, clarity, and validity.

· Prepare for and participate in audits and inspections conducted by regulatory bodies and clients, ensuring compliance and readiness.

· Collaborate with various sites and Pharmacovigilance service providers to facilitate smooth information flow and timely submissions to regulatory authorities.

· Verify and archive documents related to Medical Information and Pharmacovigilance.

· Provide support to affiliated companies on Pharmacovigilance activities.

· Undertake additional responsibilities as assigned by the supervisor.

Qualifications

· A Bachelor's degree with 3-5 years of experience in Medical Information operations within the pharmaceutical sector.

· Preferred hands-on experience with IRMS software.

· Exceptional written and verbal communication skills in English.

· Strong professional telephone etiquette.

· Ability to adapt, organize personal workload, and effectively manage competing priorities.

· Keen attention to detail and accuracy, maintaining high-quality standards consistently.

· Capacity to build and sustain effective working relationships with colleagues, managers, and clients.

· Openness to learning new skills and flexibility to meet business needs.

· Utilize knowledge and expertise to contribute to process improvements.

· Experience in Lifecycle safety (Pharmacovigilance, Medical Information, Aggregate Reporting, Risk Management, etc.) is a significant advantage.