Sr. Medical Information Specialist

2 months ago

Denville, United States Ingenus Full time
Job DescriptionJob Description

 

· Provide phone support to health care professionals, customers and patients, involving receipt and tracking of medical inquiries, adverse events, product quality complaints, and other types of calls as required.

· Receive and document incoming telephone calls, fax or emails from various sources including business partners during regular weekday business working hours.

· Establish and maintain effective team communications i.e. provide regular feedback to the local management team on project metrics, out-of-scope work challenges/issues, and successes.

· Writes the SOPs and Working Instructions in order to implement the Medical Information receipt system and ensure compliance to FDA regulations and timelines.

· Triage incoming reports for completeness, legibility, and validity.

· Preparation for, participation in, and follow-up on audits and inspections by regulatory agencies and clients.

· Coordinate with various sites and PV service providers to ensure smooth process flow of information and timely submissions to regulatory agencies.

· Verification and archival of documents related to Medical Information/Pharmacovigilance.

· Support to group companies on PV activities.

· Any other work assigned by the supervisor.

Requirements and Qualifications:

· Bachelor’s degree with 3-5 years’ experience in Medical Information operations related to pharmaceutical Industry.

· Hands on experience on using IRMS software is preferred.

· Excellent written and verbal skills in English.

· Excellent professional telephone behavioral skills.

· Ability to work flexibly, organize own workload and effectively manage competing priorities.

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

· Ability to establish and maintain effective working relationships with coworkers, managers and clients.

· Willingness to learn new skills and flexibility to support business needs

· Apply knowledge and expertise, to contribute to and provide solutions to process improvements

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

 

Company DescriptionIngenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.Company DescriptionIngenus Pharmaceuticals wants to hear from you. Ingenus Pharmaceuticals is at the forefront of the rapidly growing generic medication industry, delivering access to safe, quality medications to U.S. consumers all across the healthcare continuum. Our company is built around the principles of innovation and ingenuity, a world-class leadership team, and—most importantly—the best and brightest people in the pharmaceutical industry. Are you ready for a new challenge? Do you enjoy working with a diverse group of patients, suppliers and partners? Then come to Ingenus, where you can truly make a difference; where together, we change the world, one medication at a time. We set high standards and reward them with competitive benefits. If you consider yourself a standout in your profession, let’s talk to find out if we are the right fit for you.

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