Case Processing(3-5Years), Pharmacovigilance
- Mitocon Biopharma
- 3 - 5 years
- Hyderabad
- 5 years ago
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Job Description
Job description
Scope of Work(Job Description):
Process adverse event information received by the Drug Safety and Pharmacovigilance department and assist in the preparation of internal and external reports.
Assist in the ensuring ICSR readiness for inclusion in individual and aggregate reports (PSURs, PADERs, etc.)
Review adverse event information received for completeness and consistency, initiate case follow-up activities/AE query management, and independently generate narratives in accordance with department processes.
Perform quality control activities to ensure complete and accurate case information has been entered into the drug safety database.
Follow company processes and guidelines for case management and closure activities, and adhere to company templates and guidelines for documentation and communications.
Ensure compliance with corporate and departmental standard operating procedures
Communicates product safety issues to team members in a timely manner.
Contributes to presentations, discussions, and data summaries on safety issues at meetings with external and internal partners.
Participate in audits and inspections as SME for global case processing.
Ensure Deviations and CAPAs are followed up on and closed in due time
Perform other activities as directed by Drug Safety and Pharmacovigilance management.
Perks and Benefits
Opportunity to work from HomeJob Classification
Industry: Medical, Healthcare, HospitalsFunctional Area: Other,
Role Category: Other
Role: Other
Employement Type: Full time
Education
Under Graduation: B.Pharma in PharmacyPost Graduation: M.Pharma in Pharmacy, PG Diploma in Any Specialization
Doctorate: Doctorate Not Required, Any Doctorate in Any Specialization
Contact Details:
Company: Mitocon Biopharma Pvt LtdLocation(s): Hyderabad
Keyskills: Drug Safety Associate case processing M pharmacy B pharmacy ICSR pharmacovigilance Pharm D narrative content writer
Mitocon Biopharma
Mitocon Biopharma is in the business of improving the world's health. We do this by providing end to end pharmacovigilance services that help clients across the globe transform scientific discoveries into new treatments and we are always coded to care. From clinical trials to regulatory, technical, ...
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