Job Id: THR-IN1702
Job Description:
ü Ensures ongoing evaluation of the overall safety Drug
profile
ü Performs review of ICSR, including coding & causality
assessments.
ü Provides contribution & performs review of aggregate
reports, responses to Authorities
ü Provides input into signal management activities
ü Support safety evaluations
ü Performs aggregate safety data review
ü Provides contribution into process improvements
activities, ensuring regulatory compliance.
ü Participates in due diligence activities
ü Provides pharmacovigilance and drug safety support for
internal and external customers
ü Maintains knowledge of international regulation
ü Participates in departmental activities to ensure
internal audit and regulatory inspection readiness
ü Contributes to the training, leadership and continuing
education for all departmental staff
Skills:
ü A minimum of 5 years of experience in PV, with at least 2
in clinical field at a Pharmaceutical, Biotechnology company or CRO
ü Knowledge and understanding of national and international
regulation and drug safety practices
ü Strong knowledge of individual AE case report processing
& review
ü Knowledge of medical aspects of drug safety in pre- and
post-marketing safety practice
ü Experience with safety databases (ARISg) and safety coding
dictionaries (MedDRA, WHODRUG)
ü Oral and written communication skills
ü Teamwork and interpersonal skills
Required Education: Pham D degree required
Salary: Not
Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category: R&D
Role: Pharmacist/Chemist/Bio Chemist
Employment Type: Permanent Job, Full Time
Company
Profile:
Teelia
consulting India private limited is a french company operating now in India. We
are specialized in pharma and biotech services.
Recruiter Name: Fares MADI
Contact Company: Teelia
consulting India private limited
Address: 1
- SIDCO Industrial Estate Guindy Chennai, 600 032Chennai, Tamilnadu, India
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