Drug Safety Associate (1-3 yrs)
Drug Safety Associate
1 - 3 yrs
1,00,000 - 3,00,000 P.A.
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 Argus database experience is preferred.
- 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
- Masters degree in pharmacology or equivalent/licensed pharmacist/MBBS/BDS with diploma Clinical Research and experience in regulatory reporting (from English medium)
- Strong pharmacovigilance experience and adverse event reporting with a company or clinical research organization is preferred
- 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
Salary:INR 1,00,000 - 3,00,000 P.A.
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role:Clinical Research Associate/Scientist
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
Please refer to the Job description above
UG:Any Graduate - Any Specialization
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