Pharmacovigilance Associate, Drug Safety Associate, Regulatory Affairs Associate

Summary

1. Spearheaded the implementation of SAP program
2. Assessed, evaluated, audited, verified Quality agreements with service
providers
3. Supported the Regulatory Affairs team to ensure timely arrangement of
documents and review of reports for submission of CTD to the concerned
authority
4. Carried out need-based Risk Assessment
5. Reviewed 2-3 draft BMR / BPR in a day for the preparation of Master
BMR/BPR.
6. Performed IPQA/IPQC related activities of OSD
7. Reviewed the Validation Master plan and ensured its compliance
8. Planned and executed process validation of pharmaceutical products and nonroutine validations
9. Prepared and reviewed the Annual Product Quality Review Report
10. Handled Quality Management Systems like change control, deviation, and
investigation related to equipment and Product & propose the necessary PreImplementation check

Expectations

I have hands-on experience as a Quality Assurance Officer in the manufacturing of Pharmaceuticals, so the experience stated in this profile is of the same. As I am enthusiastic to restart my career and transition to other fields in Healthcare and patient safety, I seek opportunities from employers who will help me grow, working towards our objectives mutually.

Employment Preferences

Expected Base Salary

**0,000 INR

Academic Degree

Experience

Skills

• Pharmacovigilance
• Drug Safety Associate
• Regulatory
• Medical Writer
• Quality Assurance