Pharmacovigilance Associate Manager

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CONTACT

Address : S Monaco St, Denver, CO ****7

Phone : 720-***-****

Email : advavn@r.postjobfree.com

SKILLS

• Pharmacovigilance

• Deviation Management

• CAPA Management

• Project Management

• Training and Compliance

• Client Collaboration

ACCOMPLISHMENTS

• Contributed towards process

optimization by leveraging relevant

technology which resulted in reduction

in time and effort by 15% and improved

quality by 20%

• Identified and mitigated potential risks

thereby adhering to deadlines and

delivering ahead of timeline.

• Ensured business continuity by

covering down time, holidays and by

managing project scalability.

• Ensured every project is “Audit Ready”

three months from its initiation.

EDUCATION

Master of Pharmacy: Pharmaceutics,

08/2012

PES College of Pharmacy, India

Bachelor of Pharmacy: Pharmaceutical

Sciences, 11/2009

Acharya & B.M Reddy College of Pharmacy,

India

PROFESSIONAL SUMMARY

Highly motivated pharmaceutical professional with overall 10 years of experience which includes pharmacovigilance, data monitoring, analysis, and reporting. 3+ years of experience as a Project Lead managing Pharmacovigilance (PV) project, ensuring on-time client deliverables of highest quality. Advanced communicator with all levels of stakeholders. WORK HISTORY

Pharmacovigilance Associate Manager, 12/2014 to 07/2022 IQVIA

• Performed end to end case processing into ArisG database.

• Monitoring, analyzing, and reporting of Adverse Events (AE) from clients’ digital properties.

• Experience in quantitative and qualitative analysis of healthcare related data from social media platforms and customer engagement programs (CEP) around leading pharmaceutical brands

• Ensured training and compliance for multiple Pharmacovigilance projects.

• Contributed towards Risk Management, Deviation, and Corrective Action & Preventive Action (CAPA) management, Client Audits and Regulatory Inspections

• Worked closely with QA team for systematic monitoring and evaluation of various project aspects to ensure standards of quality

• Project lead and in charge of overseeing and coordinating completion of pharmacovigilance projects

• Responsible for creation and signing-off of project delivery documentation including Statement of Work (SoW), Standard Operating Procedure (SoP) and Work Instructions (WI)

• Liaised between onshore client contacts and offshore delivery and technology teams to ensure smooth completion of projects. Reviewer – I, 05/2014 to 09/2014

Apotex Inc

• Handled Market Complaints in Group Quality Assurance Team, deviation for identified gaps in good manufacturing practices and implemented corrective and preventive action (CAPA) and ensured compliance.

• Looked after training effectiveness for SOP training, GMP/GDP training etc. Sr. Associate, 05/2012 to 05/2014

Mylan

• Identified and implemented innovative training methodologies such as, Learning Management System (LMS) across all sites.

• Ensured Training compliance on various requirements at manufacturing sites, identifying gaps, participating in investigation, proposing Corrective and Preventive Action (CAPA) for identified gaps.

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PARAMITA MAJUMDAR

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