Accomplished Operation Specialist II with extensive experience at IQVIA, demonstrating expertise in strategic planning, compliance and audit, and client management. Proven track record in providing innovative solutions and process improvements, leading employee engagement initiatives, and mentoring new hires. Recognised as a key subject expert and process champion, with a strong background in medical safety, adverse event reporting, risk management, and regulatory compliance. Adept at utilising pharmacovigilance databases and software to ensure high-quality case processing and safety data review. Career goal includes leveraging analytical skills and problem-solving abilities to drive continuous improvement in drug safety processes. Skilled in managing logistics and coordinating team efforts to streamline operations. Effective communicator with knack for problem-solving and fostering teamwork. Proven ability to adapt quickly and maintain focus under pressure, ensuring smooth workflow and timely results.
Hi, I’m
Sumit Pramanik
Drug safety
Bangalore,KA
Summary
Overview
12
years of professional experience
1
Certification
Work History
Iqvia
Operation specialist II
07.2017 - Current
Job overview
- Provided Innovative solution and Process improvements to simplify work processes, developed training and guidelines specific for staff
- Developed budding SMEs by helping them groom and trained them to achieve standard levels of expectations
- Planned mentoring for new hires
- Led Employee Engagement team and contribute in related activities
IQVIA
Operation specialist I
06.2014 - 07.2017
Job overview
- Case Processing and Quality Review of Safety Data according to valid regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements with activities
- Involved in other case processing related activities including partner reconciliations, acknowledgement, mailbox management, quality consistency checks
- Experienced in processing all safety report types including literature, clinical trials, and solicited cases
- Provided mentoring for new employees on product specific convention and processing of ICSR
- Identified as Process Champion/Key subject expert in the team
- Represented team as SME in customer audit
- Worked with peers in developing new processes by providing ideas, helped in document preparation, presentations, and team trainings
Oviya medsafe
Pharmacovigilance Associate II
02.2013 - 06.2014
Job overview
- Preparation of PSURs, Addendum to Clinical overview summary report, Risk Management Plan as per companies controlled documents (e.g
- SOPs, WIs, Guide) and guidelines
- Accountable for performing the appropriate clinical assessments (including the assessment of seriousness, labeling and company causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements
- Helped team in achieving high customer satisfaction by adhering to turnaround time and recognized as best quality achieved consistently in the team
Education
Sheffield Hallam universitySheffield
Master in science from Molecular pharmacology and biotechnology
07.2010
University Overview
JSS College of PharmacyOoty
M.Phamacy from Pharmaceutical Biotechnology
06.2005
University Overview
JLCPNagpur
Bachelor in pharmacy from Pharmaceutical science
06.2003
University Overview
Skills
- Strategic Planning
- Compliance and audit
- Client Management
- Medical safety
- Adverse event reporting
- Risk management
- Analytical skills
- Problem-solving
- Drug safety processes
- Pharmacovigilance regulations
- Industry standards
- Team leadership
- Project management
- Pharmacovigilance databases
- Pharmacovigilance software
- Critical analysis
- Microsoft Office proficiency
- Decision support
- UAT process testing
- Process improvements
- Regulatory compliance software knowledge
Certification
- Learn to Excel program-2020, IQVIA, 2020
- Barnett 2015 Good Clinical Practice exam, IQVIA, 2015
- Certificate of appreciation from client, To ensure patient safety 2018, 2018
Accomplishments
Accomplishments
- Well-versed with PowerPoint, Excel, Word, MS lists.
- Excellent verbal, written, interpersonal and communication skills to lead teams.
- Significant experience in internet-mediated scientific search and data mining.
- Trained in ICH-GCP, Schedule Y, FDA, EMA, MHRA and other regulatory requirements.
- Trained and working along the guidelines of GVP, EUDRALEX Vol.9A, Vol.10, 21 CFR of the FDA.
Languages
English
Software
Argus
Arisg
Availability
See my work availability
Not Available
Available
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Affiliations
Affiliations
- Pharmacy council of india
- Learn to excel
Work Preference
Work Type
Full TimeLocation Preference
On-SiteHybridImportant To Me
Company CultureWork-life balanceCareer advancementPersonal development programsHealthcare benefitsFlexible work hoursPaid time offPaid sick leaveInterests
Signal management tools in pharmacovigilance
Data management tools
Project management
Timeline
Operation specialist II
Iqvia
07.2017 - Current
Operation specialist I
IQVIA
06.2014 - 07.2017
Pharmacovigilance Associate II
Oviya medsafe
02.2013 - 06.2014
Sheffield Hallam university
Master in science from Molecular pharmacology and biotechnology
JSS College of Pharmacy
M.Phamacy from Pharmaceutical Biotechnology
JLCP
Bachelor in pharmacy from Pharmaceutical science
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