Product Safety Specialist
4 days ago
Product Safety Specialist - Remote
37.5 hours/Week or 7.5 Hrs/day
Responsible for receipt and documentation of safety information for Marketed and Investigational Products. Interacts with health professionals and consumers to obtain and follow-up reports of possible adverse events with Client products. Provides product information to health care professionals, and consumers. Codes and enters information into the global safety database. Verifies the accuracy, completeness and validity of information for each adverse event report for which he/she is responsible. Assures consistency of case records and documentation.
1. Accurate and timely data entry of both domestic and foreign adverse event information into the PSSS (Product Safety Surveillance System) consistent with the ARISg coding manual, SOPs/WIDs, process flows and established time frames within the ARISg workflow. Full understanding of the products' Company Core Data sheet, PI, and/or IB for accurate labeling and listedness. Perform appropriate and timely follow-up per department guidelines, including accurate and thorough communication documentation within the case. Maintain proficiency in the utilization of the PSSS, including MedDRA coding. 65%
2. Ensure accurate and timely submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes. Utilize ARISg for reporting and confirmation of successful distribution and acknowledgement. 1 5%
3. Maintain sufficient knowledge of all Client products to ensure professional and knowledgeable discussions with consumers and healthcare providers and dissemination of accurate product information in response to queries. Provide high level customer service to consumers, health care professionals and internal customers. 10%
4. Complete all required training within the timelines provided so as to ensure knowledge of all relevant corporate and departmental SOP's, SWP's and WID's. 10%
Ensure timeliness in regulatory compliance
5. Gather sufficient information to assess the medical significance of an adverse event report, while at the same time assuring the information provided adequately addresses the concerns of the health care provider and/or consumer.
Healthcare professional required.
US license not required.
Minimum of bachelor's degree in healthcare field.
Minimum 2 to 4 years in industry application of clinical medicine/pharmacy with a minimum of 1 year in pharmaceutical drug safety
Experience in verbally interviewing and/or providing medical information to health care professionals and consumers
Application of clinical medicine to patient care
Medical terminology and standards of patient care
Computer proficiency
IMPORTANT:
1) Bachelors degree
2) Healthcare professional
2) Minimum 2-4 years of clinical experience with minimum of 1 successful year in pharmaceutical drug safety
3) Ability to apply clinical medicine to patient care
4) Proficient with medical terminology and standards of patient care
5) Computer proficiency
6) Will not be assigned to toll free phone lines but will function as "case owner " and have full responsibility of adverse event report management from beginning to end
7) Pursuing follow up information as needed and sending appropriate documents to consumers/HCP's
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r
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Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.
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