DescriptionThis is a hybrid position which requires 2-3 days onsite at our Ridgefield, CT campus.
Responsible for the review, regulatory assessment and prioritization of adverse event and other product related information submitted to the company from clinical trial investigators, health care professionals and consumers. Through collaboration with Risk Management (RM) Physicians, Study Coordination, Regulatory Affairs, Biostatistics and Data Science (BDS) and Clinical Operations, this position ensures that adverse event information regarding the company's products is submitted to the appropriate business units and health authorities. The Triage Manager ensures that adverse event cases contain complete medical information and are processed in a timely manner for submission to authorities as per federal regulations. The Triage Manager requests additional information from adverse event reporters where necessary in order to provide a complete medical story for the case.
Duties & Responsibilities- Responsible for review and regulatory assessment of adverse event information received by the company. Determine that the information received meets the definition of an adverse event; determine seriousness of case, routing non-adverse events to appropriate party.
- Apply clinical judgement to identify missing pertinent medical data required for a complete adverse event case.
- Request additional medical information where necessary.
- Determine regulatory reporting disposition of case as per federal regulations.
- Ensure collected adverse drug events are processed with high quality according to local and global SOPs and Working Instructions.
- Coordinate with appropriate departments for cases containing product complaints and/or Medical Information Requests.
- Set the regulatory path by assigning seriousness and causality in accordance with FDA and global regulations.
- Act as subject matter expert for non-HCPs, peers and physicians for issues relating to adverse event collection, intake and processing as well as standard medical inquiries.
- Collaborate with Risk Management Physicians to confirm accuracy of adverse event information reported and collected.
- Participate in departmental projects/activities as deemed appropriate.
Requirements- Bachelors degree or higher in nursing, pharmacy or related health care field from an accredited institution required.
- Minimum of three (3) years of relevant clinical practice required.
- Minimum of three to five (3-5) years of pharmaceutical industry experience with two (2) years of experience processing adverse event information preferred.
- Working knowledge of FDA regulations preferred.
- Ability to make decisions independently, accountable for decisions made required.
- Ability to prioritize workload and perform under stress in situations in which working speed and sustained attention are critical aspects of the job required.
- Application of medical knowledge to collect, interpret and reconcile medical information in order to precisely capture the adverse event as reported required.
- Must be able to communicate and resolve issues effectively with inter/intra departments through strong interpersonal skills required.
- Proficient in electronic data capture tools (i.e. ARISg) and Microsoft-based applications (i.e., Word, Excel, Powerpoint) preferred.
- Must have problem solving skills and the ability to organize time effectively required.
- In addition to understanding all company policies, procedures, guidelines and working instructions regarding the reporting of adverse events, must be familiar with clinical trial protocols, product labels, company core data sheets, investigator brochures, medical terminology dictionaries and federal regulations.
Desired Skills, Experience and AbilitiesThis position offers a base salary typically between $140,000 and $222,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
