Pharmacovigilance - Deputy Manager / Manager
by PIRAMAL ENTERPRISES LTD in Mumbai, Goregaon
Experience: 5 to 9 yrs. Posted on: 15 Oct
Department : Pharmaceutical R&D (Group - Clinical)
Job Responsibilities: - Review and conduct medical assessments of !CSR's and PSURs
- Monitor adverse events reporting and PSUR submission within timelines and requirements as applicable to regulatory authority and as per company processes defined in SOP
- Review and update SOP's, other safety related documents related documents: safety section of protocols, CSR. safety management plan. CCSI.18 safety sections and SDEA
- Respond to queries and requests related to safety of products and the pharmacovigilance system
- Review of coding and SAE reconciliation
- Validation of database during upgradation
- Prepare for internal or external/regulatory: audits
- Guide and manage team of drug safety executives for their daily activities, expedited cases and training and ensure the performance of the team
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role: Clinical Research Manager
Keyskills: safety management SAEsafety
Desired Candidate Profile
Education: UG - MBBS
PG - Any Postgraduate
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Location:Goregaon, Mumbai
Education:MBBS
Experience:5-9 years
Desired Skills:- MBBS background with 5-9 years experience, with minimum 3-5 years experience in Pharmacovigilance in pharma/service industry
Company Profile
PIRAMAL ENTERPRISES LTD
Visit www.piramal.com
Contact Details
Recruiter Name:research.recruitment@piramal.com
Contact Company:PIRAMAL ENTERPRISES LTD