WORK FROM HOME | JOB OPPORTUNITY FOR PHARMACOVIGILANCE AT PHARMALEAF INDIA PVT LIMITED

ABOUT PHARMALEAF PVT LTD:

PharmaLeaf is an independent consultancy providing customized technical and regulatory support to several Global and Indian companies, Contract Research Organizations, Laboratories, Logistics etc., i.e. any stakeholder involved with drug research, product development, clinical trials, testing, manufacturing and supplies. PharmaLeaf’s expertise lies in “building consensus” on regulatory challenges to successfully navigate approvals for complex projects.

HIRING NOW!! 

Pharmaleaf India Pvt Ltd (a global regulatory organization, headquartered at Bangalore, India) is looking for a Dynamic and efficient “Operations Specialist (Regulatory Reporting)-FTE’s (Contract)” proficient in: Pharmacovigilance 

Key attributes: Ability to prioritiz, adhere to tme-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 licences 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. 

Responsibilities: 

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 an processes 

Should have experience and knowledge of various formats of {CSR reporting that is submitted to Regulatory authorities, like xml format for EVWEB upload, E2B gateway reporting and transmission, Portal submissions, couner and manual email submissions of CIOMS, MEDWATCH. 

Case Processing (ICSR processing (Drug Safety Associate) 

Work hours: Work from home with adequate Wi-Fi connectivity til the Covid situation improves, post Covid might be required to move to Bangalore/ Thane/ Kochi. 

‘Attractive package and multinational exposure 

it you think you are a fit or match reach out to us on: Email: info@pharmaleaf.co