Location
Mysore | India
Job description
- Analyzes, reviews, and interprets safety data, both non-clinical and clinical and any other relevant sources
- Authoring and review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities`
- Performing literature search and presentation of relevant articles for the aggregate reports.
- Management and reconciliation of relevant process trackers
- Subject matter expert (SME) along with training and mentoring ofindividuals
- Generation of Periodic Safety Line Listings (PSLL) from safety database
- Exposure in handling regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries.
- Providing reliable support for high priority Ad-hocactivities
- i. Interacting withappropriate clientpersonnel to resolve issues related to the Aggregate reports as per clients policies
- Ensuring that deliverables to the clientscomply withthe relevant regulatory requirements and are sent to the client within agreed timelines
- Contributes to safety and pharmacovigilance trainingprograms
- Collaborates with Regulatory Affairs to ensureappropriate reportingof pharmacovigilance and drug safety information to regulatory agencies and prescriber community
- Training and mentoring of Pharmacovigilanceassociates
EDUCATION AND EXPERIENCE REQUIRED:
- Minimum 7 years of experience in authoring and reviewing along with team management of medical writers
- Degree in Life Science/Pharma or Equivalent
Job tags
Salary
