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Safety Clinical Research

Location:
United States
Posted:
October 16, 2020

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Resume:

Manasi Alve

BDS, MS, MBA

Phone: 857-***-**** Email: adg09o@r.postjobfree.com

Objective: Highly motivated healthcare professional with more than 7 years of experience, seeking full time positions, with the goal of making a significant contribution to the organization’s growth, while being true to the company’s core values.

PROFESSIONAL SUMMARY

Sound understanding of PV operations, signal detection and risk management.

Demonstrated ability to lead and contribute in weekly meetings with global safety and risk management teams.

Experience in handling teams, assigning work, arranging and leading team meetings.

Experience in interacting directly with customers at client site; and working with onsite and remote teams.

Managed and assured timely movement of project work through the process steps, in accordance with governing SOP’s, SLA’s, global regulatory guidelines, work instructions and client expectations.

Handled daily interactions with client and vendors, located globally.

People management skills include teamwork and timely communication with all stakeholders.

Ability to work in a fast-paced environment in a team/matrix environment as well as independently.

RELEVANT SKILL SET

ARISG, ARGUS, IRT, SiCO and LISA databases.

Familiar with US, Europe, Japan and ROW requirements; for drugs and medical devices.

eCTD, ANDA, NDA, 510(k), BLA and PMA submissions.

Drug regulatory guidelines and documents like ICH GCP, GMP, GVP, GLP, CMC, CFR Title 21, REMS, RMP, CTD, RCA, CAPA, Labeling, Aggregate safety reports like DSUR, PSUR, PBRER and PADER.

Medical device regulations- 21 CFR 803, EU Medical Devices Directive and ISO.

MS Office (Word, Excel Access, Outlook and PowerPoint), LMS, EndNote and Adobe Acrobat.

WORK EXPERIENCE

Regulatory Post Market Specialist May 2019 - Present

Intuitive Surgical, Sunnyvale, California

Post market safety vigilance of complaints in Trackwise.

Manage volume of complaints, while ensuring quality and adhering to regulatory timelines.

Support systems and processes that Post Market Surveillance requires to manage complaints, regulatory reporting, and other related processes.

Identify gaps in the complaint process and support implementation of corrective plans and other solutions to ensure continued compliance with applicable regulations.

Support the team in successful and timely complaint management, regulatory reporting, and meeting business goals.

Senior Drug Safety Associate/ Acting Team Lead Sep 2014 - Dec 2016

Cognizant, India (Client- Novartis)

In charge of launching a Pilot project for a new safety software SiCO (Signal Content Owner).

Designed work instructions (WI) for the project and helped define Standard Operating Procedures (SOP’s).

Led training and built a signal management team consisting of 6 associates.

Acted as a single point of contact for the leadership and the global safety teams.

Ensured quality and overall audit readiness for the project.

Pharmacovigilance Scientist Level II May 2012 - Jul 2014

TCS, India (Client- Roche)

End to end Pharmacovigilance case submissions for ICSR and Literature (Clinical and Post Market).

Worked closely with the SME’s to ensure timely regulatory submissions.

Dentist (Indian License) Sep 2011 - Sep 2012

Single handedly managed a dental practice and treated patients for dental diseases.

Rotational Internship Aug 2010 - Aug 2011

Interned in a rural setting to gain comprehensive understanding of rural dental needs and treatments.

EDUCATION

Master of Business Administration (online)

Campbellsville, KY

MS in Drug Regulatory Affairs and Health Policy Sep 2017 - Dec 2018

Massachusetts College of Pharmacy and Health Sciences, Boston, MA

Certification in Clinical Research Jan 2012 - Aug 2012 Academy for Clinical Excellence, Mumbai, India

Bachelors in Dental Surgery (Registered Dentist in India) May 2006 - Aug 2011

Tatyasaheb Kore Dental College and Research Center, Kolhapur, India

MS PROJECTS

Pharmacovigilance: Comparison and analysis of different data mining sources for signal detection.

Protection of Human Research Subjects - Ethical concerns of surrogacy in India.

AWARDS AND HONORS

•Received ‘Spotlight of the Year’ award for exemplary performance at work in Cognizant in 2016



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