Highlights:Having worked within the industry for over 7.6 years, during my career I have had many achievements, including Consistent performer in productivity and plays an important role in the team when requires. I have developed a wide range of skills that would meet, and exceed the expectations for the role. Have been very proactive and extended full support for prioritizing the cases and preparing the work allocation for Project. The cases reviewed by me had no findings or feedback from the clients. Have been cordial and a cooperative team player, used all the opportunities in mentoring other team members, guiding them through the challenges they faced while processing cases for the products transitioned internally. Provided outstanding contribution to the team in terms of exceptionally high productivity and a good quality. Flexible in my approach and provides support to the team whenever the team needs. By considering all my effort hard work and knowledge in Pharmacovigilance, I have got Maximum rating of 5 in my year end performance review and I have been promoted to the position of Sr Operations Specialist in grade 30 in April 01, 2014. I would enjoy the opportunity to bring this level of success to Quintiles Research (India) Pvt. Ltd. Pharmacovigilance Department.

Skills:Pharmacovigilance, drug safety, clinical research coordinator

Goal:To join a career path in growing organization with professional environment and facing new challenges in the field of pharmacy where my potential as a professional will get ample opportunities for career advancement by shouldering broader responsibilities.

Certification:I have a post graduate degree in Clinical Research from Crain field Health, UK and bachelor’s degree in Ayurvedic Medicine & Surgery (BAMS) from Rajiv Gandhi University of Health Sciences, Bangalore.

Senior Pharmacovigilance Operations Specialist 04/01/2014 - current
Quintiles Research (India) Pvt. Ltd. Pharmacovigilance Department, , India
Senior Pharmacovigilance Operations Specialist
Pharmacovigilance Scientist (Team Lead). • Case Receipt and /or Case Processing through workflow : Initial receipt, Database searches as necessary; registry, Triage o f incoming cases to determine seriousness for • Prioritization of daily workflow • Completion of literature searches as necessary • Completion of case processing (Case data entry, labeling, approval numbers, manual coding, narrative writing /) and Quality review: • Clarification of unclear or illegible information from the Local Safety Officer or Call Centre and customer communication as per the project requirement • Discuss source documents, coding conventions and ad-hoc queries with Pharmacovigilance Physician • Completion of protocol request forms as necessary • Preparation of deviation memo as necessary • Approve deletions as necessary and approve admin edits as necessary • SUSAR's & Clinical Study-End Procedures to include un-blinding and clinical database reconciliation • Other Case processing related activities (e.g. review of consistency checks, reconciliations etc). • Supervising product specific daily work load: Prioritization and organization of daily workload with the team to maintain regulatory compliance and quality standards. • Review of Managers daily reports to ensure compliance. • Monitoring of edit check reports. • Processes and Procedures : Continuing awareness o f company procedures and guidelines to maintain regulatory compliance. • Supervising product specific daily work load: Continuing awareness of company procedures and guidelines to maintain regulatory compliance. • Participations in Customer projects, preparations or audits, inspections and Business continuity plan. • Mentoring: Enhancement of the formal training program, through the provision o f ongoing, on -the -job guidance and support. • Process & Technical Expert: A ct as key con tact point, expertise for others within the team along with the external contacts.--
Pharmacovigilance Operations Specialist (Senior Drug safety associate) 05/04/2011 - 03/31/2014
Quintiles Research (India) Pvt. Ltd. Pharmacovigilance Department, , India
Pharmacovigilance Operations Specialist (Senior Drug safety associate)
As Senior Drug Safety Associate • Performing case processing for serious adverse events of serious and non-serious adverse drug reactions of spontaneous and clinical trials cases. • Evaluation (QR) and QC of Serious and Non-Serious Adverse Event • Inbound Triage, Case processing and doing work allocation. • Case Processing and completion of full case information on the database, culminating in quality review to ensure accuracy and completeness. • Triage of incoming case to determine the seriousness for prioritization of daily work flow • Confirmation of safety coordinator case registry data • Database search as necessary • Completion of literature search as necessary. • Completion of data entry including narrative writing • Completion of label approval, manual coding and quality review steps. • Clarification of unclear or illegible information from the local safety officer or call center. • Discus source documents, coding conventions and ad-hoc quires with medical assessment physician • Completion of protocol request form as necessary. • Preparation of deviation memo as necessary • Request deletions as necessary. • Single case unblinking • Participation in inspection and audits as required. • Participation in local or global project teams. • Training and mentoring--
Clinical Research Coordinator 12/01/2009 - 04/30/2011
Max Neeman Medical International Ltd, Bangalore, India, , India
ICF processing, Patient Identifying, Recruiting, Formulating source documents, • Assessing AE and SAE, SAE & AE form filing, narrative writing, obtained PI signatures, SAE reporting procedures according to regulatory compliance;
As Clinical Research coordinator • ICF processing, Patient Identifying, Recruiting, Formulating source documents, • Assessing AE and SAE, SAE & AE form filing, narrative writing, obtained PI signatures, SAE reporting procedures according to regulatory compliance; • CIOMS, SUSAR other safety related documents notification to IRB and EC and other regulatory • Managing clinical trials Project • Data collection, Data Entry in CRF/ECRF entry ,query resolving--
Clinical Research Coordinator 07/01/2007 - 11/30/2009
Kidwai Memorial Institute of Oncology Bangalore India, , India
ICF processing, Patient Identifying, Recruiting, Formulating source documents, Assessing AE and SAE, SAE & AE form filing, narrative writing, obtained PI signatures, SAE reporting procedures according to regulatory compliance;
As Clinical Research coordinator • ICF processing, Patient Identifying, Recruiting, Formulating source documents, • Assessing AE and SAE, SAE & AE form filing, narrative writing, obtained PI signatures, SAE reporting procedures according to regulatory compliance; • CIOMS, SUSAR other safety related documents notification to IRB and EC and other regulatory • Managing clinical trials Project • Data collection, Data Entry in CRF/ECRF entry ,query resolving--

Rajiv Gandhi University of Health Science. Bangalore 05/01/1996 - 05/01/2004
, , India
Degree: Bachelor's Degree
Major:Medicine
Bachelor of Ayurvedic Medicine & Surgery. (BAMS)

Praveenkumar Resume 7.6 years in Pharmacovigilance/drug safety