Pharmaleaf India Pvt Ltd (a global regulatory organization, headquartered at Bangalore, India)
Dynamic and efficient “Operations Specialist (Regulatory Reporting)-FTE’s (Contract)” proficient in: Pharmacovigilance
Key attributes: Ability to prioritize, adhere to time-lines, problem solving capabilities, strong team and liaising skills
Qualifications: Bachelor’s degree in life sciences or related field (BPharm, MPharm, PharmD)
Industry experience: 2 years and more (Regulatory reporting + Case processing experience) Relevant experience: 06 months – 01 year.
Job Profile:Experience in post marketed ICSR Regulatory Reporting or any kind or Regulatory Submissions.
Experience of “determining and assessing ICSR report ability to various regulatory authorities based on appropriate regulatory intelligence”.
Knowledge about concepts of post market reporting ICH E2D should be beneficial on cross reports across licenses of a pharmaceutical product.
Experience in ICSR regulatory submission and regulatory guidelines for vaccines for various countries. Knowledge of FDA guidance on Vaccines, VAERS system and EMA Vaccine guideline, GVP VI will also be helpful.
To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming:Knowledge of FDA guidance on Vaccines, VAERS system and EMA Vaccine guideline, GVP VI will also be helpful.
Knowledge of automated and manual scheduling of regulatory reports in safety database. Includes initial report, follow up regulatory report, amendment report scheduling, nullification report, downgrade report.
Ensure to meet quality standards per project requirements; Ensure to meet productivity and delivery standards per project requirements: 100% compliance towards all people practices and processes
Should have experience and knowledge of various formats of ICSR reporting that is submitted to Regulatory authorities, like xml format for EVWEB upload, E2B gateway reporting and transmission, Portal submissions, courier and manual email submissions of CIOMS, MEDWATCH. Case Processing (ICSR processing-(Drug Safety Associate)
Work hours: Work from home with adequate Wi-Fi connectivity till the Covid situation improves; post Covid might be required to move to Bangalore/ Thane/ Kochi.Attractive package and multinational exposure
If you think you are a fit or match reach out to us on: Email: firstname.lastname@example.org