Risk Management Associate

Risk Management Associate

The Risk Management Associate's (RMA) main role is to process and evaluate adverse events (AEs) received from clinical trials and/or postmarketing sources to support drug development and ensure safety and efficacy of the company's products. This includes data collection, entry, evaluation, follow up, and distribution in a timely fashion to ensure compliance with local and global regulatory reporting.

Responsibilities:

Data collection, entry, evaluation, and distribution of adverse events (AEs) in a timely fashion to ensure compliance with regulatory reporting and distribution to other sites. Reviews and codes AEs, medical history, laboratory data and drugs using appropriate event term selection in MedDRA and WHO-Drug dictionaries, determines seriousness and labeling, and determines reportability locally and globally. Works to ensure the timeliness and accuracy of expedited reports. Ensures that case details are complete and, when necessary, follows up with the reporting consumers and health care professionals to get additional information to clarify the case details. Ensures that cases are entered and handled appropriately in the company?s safety database according to the established guidelines. Interacts with consumers, health care providers, company representatives, project teams, clinical sites, CROs, and other members of RM to ensure timely, accurate, consistent and compliant processing of safety data. Depending on case-type assignment, the RMA is responsible for the preparation of IND/NDA safety letters and regulatory periodic update reports.

Participate in the preparation of PSURs, annual reports, investigator brochures and package inserts.

Assist in planning, development and implementation of safety surveillance and risk management functions for the company's IND products by participating in the study development and startup process, and helping to create guidelines and policies.

Qualifications:

Minimum: Bachelor degree in nursing or pharmacy or health related field; strong clinical background preferred.

2-5 years clinical experience required; experience in clinical research and/or safety preferred

Good written and verbal communication skills; Good computer skills;
Good interpersonal skills and the ability to work in a team environment; Efficient in time management and multi-tasking.

Knowledge of clinical/safety databases preferred; Knowledge of FDA regulations, ICH guidelines and GCP preferred.
This job posting indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required. Incumbent may be asked to perform other duties as required.