20/11 Saranya
HR at Personnel Search

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Drug Safety Associate (1-3 yrs)

Mumbai Job Code: 284

Drug Safety Associate

1 - 3 yrs

Mumbai

1,00,000 - 3,00,000 P.A.

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 Argus 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/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 Category:R&D

Role:Clinical Research Associate/Scientist

Employment Type:Permanent Job, Full Time

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:Any Graduate - Any Specialization

Company Profile:

Personnel Search Services Pvt Ltd

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