Drug Safety Associate, @ MedVigil Clinical Reserach - Mumbai , D3

Job description

Ideal candidate must be a complete team player, should be focused on AE reporting and outsourced case processing in order to meet the timelines. Prior MedDRA and database experience is preferred.

Role:

• Processing adverse event reports
• Case processing, triage and narration writing skills
• Confirm serious and non-serious designation as well as initial and follow-up cases
• Should be familiar with medical coding
• Maintaining and updating the database
• Abiding by SOP and timelines
• Preparation for audits and inspections
• Keeping abreast with guidelines and training documents

Desired Skills and Experience

Requirements:

• Masters degree in pharmacology or equivalent/licensed pharmacist/MBBS with experience in regulatory reporting
• Minimum of 2 years of strong pharmacovigilance experience and adverse event reporting with a company or CRO
• Case processing experience, ideally with both clinical trial and post approval adverse events
• Excellent English communication skills,, both written and verbal
• Fully aware of current Pharmacovigilance regulations and legislation
• Project Management skills; good organizational, planning, co-ordination, follow up skills.
• Strong software learning skills, and willing to update skillset
• Should be fast and flexible, focused on time delivery and willing to take on new projects

About the Company:

MedVigil Clinical Research is a global CRO providing medical information and pharmacovigilance services to biopharmaceutical, generic pharmaceutical, consumer product, medical device, contract research and healthcare companies. We strive to promote drug safety by collecting, synthesizing and analyzing data from clinical trials and post marketed products. Our scientific expertise delivers accurate, consistent and current evidence based medical information to fulfill our client’s requests.