Skilled Drug Safety Scientist with knowledge of 9.6 years of experience in pharmacovigilance domain . Experience includes monitoring adverse drug reactions, evaluating safety data, implementing corrective measures, providing support and guidance for team as required. Strengths lie in strong analytical skills, sound judgment and ability to work diligently under pressure. Seeking a challenging role in a reputable organization where I can utilize my skills.
Roles & Responsibilities:
· Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
· Process current incoming cases to meet timelines.
· Provide guidance for Data entry & Quality teams.
· Follow departmental AE workflow procedures.
· Train and mentor new team members as per the requirements of the project.
· Delegate tasks and responsibilities to appropriate personnel.
· Identify and resolve issues and conflicts within the project team.
· Act as guide, coach and counselor for the team.
· Oversee, mentor, and guide the activities of the Drug Safety and Senior Drug Safety Associates. High level of proficiency in all workflow tasks.
Perform any other drug safety related activities as assigned.
Performed triage activities and later worked in the initial review team. Acted as SME in the team and did mentoring for new hires.
Case processing and Quality review in both ArisG and Argus databases.
Initial Review and Quality review of cases in AgXchange tool