A minimum of a scientific graduate degree and post graduate from a well-known institution which may include as:
MBBS or MD from any recognized university.
Candidate must have minimum 4-6 years of relevant Pharmacovigilance experience either in a pharmaceutical company or with a CRO
Experience in managing teams in Pharmacovigilance domain will be preferred.
Good understanding of clinical development processes including principles of clinical study operations, and ICH-GCP guidelines.
Undertake information processing activities with extremely high reliability with high quality and in tight timelines according to standard processes and operating procedures.
Undertake QC activity for Writing, editing and summarizing of Case Processing, PSURs, Spontaneous Case reporting, Medical/Scientific Literature search, Manual Recoding of Terms, EVPRM Creation or any other related activity as per the project requirement.
Act as a subject matter expert and help the team members with day-to-day trouble shooting activities.
Undertake or Assist in training and mentoring of team members depending upon project requirement.
Assist the manager in work allocation, compiling and reporting the project completion reports on timely basis.
Create error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to project management on a regular basis as required from time to time.
Systematically review other Associates/SAs work (both within own team, and in other PV Teams).
Participate in meetings with Client on a regular basis to understand the clients requirement for a particular project and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints.
Key skill requirement:
Excellent written and verbal communication skills
Working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required.
Core competencies for this role include:
o Analytical capabilities, familiarity and comfort with scientific and clinical data.
o Professional attitude willing to go beyond the call of duty to satisfy their clients
o Commitment to highest quality outputs, including obsessive attention to detail
o Enthusiasm and pro-activity
o Team collaborators, ability to be successful working in teams.