1. CURRICULUM VITAE
SWAMY JINUGU
Ph. No: +919985 344 514
E-mail: swamypharma33@yahoo.co.in
________________________________________________________________
Career Objective:
To obtain a job which gives me a chance to work with Innovation, Creation and Responsible in
achieving organization goals towards Mission and Vision of organization with updated
knowledge and skills through considering my areas of interest and my ultimate professional
ambition.
Work experience at Tech Mahindra (Pharmacovigilance):
I have been working as Team Lead_Pharmacovigilance at Tech Mahindra, Hyderabad since
Jul2015.
Responsibilities:
• Assigning the cases to the team members on daily basis.
• Tracking the case status and completion status on regular basis to ensure the timelines
for case delivery are met on ongoing basis
• Providing the support to the team members for any case processing related queries and
for any performance related issues
• Provide regular feedback to the team about their performance
• Responsible for performing Root Cause Analysis for any case processing related non-
compliance along with Quality team.
• Responsible for implementing the Corrective And Preventive Actions as assigned by the
senior manager
• Tracking the quality metrics for the team on ongoing basis and ensuring the quality
standards are met
• Mentoring the team members and support them in their case processing
• Responsible in meeting the timelines, compliance and quality standards as per Service
Level Aggrement
• Coordinate with senior management, team members and ensuring the efficient case
processing
• Coordinating with Client designated contact for efficient case processing and query
resolution
• Adhere to client specific and company specific guidelines for case processing.
• Attend Bi-weekly client meeting regarding the project progression (Productivity, Quality
and timelines)
• Set up yearly objectives and review performances of team ensuring best use of available
resources. Discuss and set up development plans with/for all team members to further
develop individual’s skills and potentials.
• Ensures process adherence to quality plan
• Coordinates with quality analyst and reporting manager (RM) in maintaining quality
process
• Perform additional responsibility delegated by the RM
• Set up the training plans for new hires according to the individual’s experience and job
role and ensure that training is provided to team as appropriate.
2. • Verify and confirm Billing, Quality and Compliance reports on monthly basis for 02
projects (LCPA and OTC) as Back up Manager responsibility since Jul2015.
Number of Reportees: 30
@ Trained on PMP certification (Project Management Professional) in Dec2016 at
TechMahindra
Delegated Responsibilities:
TeamLead for Baxter, S3 and Merck Data Migration projects from 25Nov2014 to Jul2015
Back Up TeamLead and Process Trainer from27Jan2014 to 25Nov2014
• Assign cases/tasks to team and keep track of the work progress
• Coordinate the team to ensure efficient case processing
• Mentoring and support associates in case processing
• Ensure the team deliver the task within timeline
• Conduct team meetings to discuss about outstanding queries, process updates and daily
briefings
• Prepare and send daily case delivery status and weekly report to client
• Prepare monthly goal sheets and KRA, take approval from RM and share with the team.
• Plan and approve the associates leave and attendance on regular basis in order to meet
the client task targets
• Build and maintain good professional relationship with Client designated contact
• Attend Client meetings on monthly basis including as and when required to discuss
about the project progress/updates
• Provide training to associates as per Client training curriculum and also ensure the team
training compliance met ( as a second delegated responsibility)
• Conduct assessment and evaluate for re-refresher training for bottom line performers if
any
• Maintain training documentation including associates C.V., job descriptions, training
transcripts, attendance, etc..for client audit
• Review and update training SOP, JDs and master training plan
Key milestones as a Team Lead:
• Met and exceeded the client expectations with respective to productivity, quality
and timelines
• Successfully completed one of the client project with high volume and quality
(100%) within timelines (in fact, one week prior to target completion date)
• Completed client audit twice without major issues
• High productivity and quality delivered throughout the project within stipulated
timelines
• Got many appreciations from Client
• Never Missed SLA (Service Level Aggrement) in any of the Project.
Number of Reportees: 39
I had the following role and responsibilities as Pharmacovigilance Associate from Nov2010
to 31Jan2012 and Quality Control Reviewer fromFeb2012 to Jan2014 at TechMahindra.
3. • Case processing and assessment of Legal spontaneous – serious, non-serious and
Marketing Program cases in Argus.
• MedDRA coding of events, medical history and therapeutic indications
• Assessment of listedness of event terms by referring CD, IB, SPC and USPI documents
• Drug coding using CDD and WHO dictionary
• Narrative writing as per SOP
• Review source documents and update all critical fields (General tab, Patient tab,
Products tab, Events tab, Analysis tab and Additional info tabs) per AURG guideline
• Update contact log
• Resolve all mandatory E2B validations
• Raise and seeking clarification (s) from client if required
• Attend training as and when needed
• Work in accordance to business requirements of client.
• Meeting tough timelines
Applications used in Pharmacovigilance: Argus, PfAST, ARISg, GDMS, eAEM, RSGT, MedDRA
and WHO coders, and other Client Applications
Work experience at Wipro BPO (Pharmacovigilance):
Worked as Pharmacovigilance Officer from 31Mar2010 to 18Nov2010 at Wipro BPO, Greater
Noida.
Differential Responsibilities:
• Case processing and assessment for solicited - serious & unrelated; spontaneous - non-
serious, related & unrelated; Regulatory, License and Literature cases in Argus as per
SOP.
• Generate HCP and Non-HCP letters as needed in DSS case process.
Work experience at Apothecaries Foundation (CRO):
Worked for Apothecaries Foundation, New Delhi as Senior Clinical Research Executive
(Promoted) Oct’ 2009 to 14Mar2010.
Responsibilities:
• Propose and coordinate training to study team on Protocol, GCP and Regulatory
requirements
• Train study team on Protocol, GCP and Regulatory requirements
• Conduct site feasibility and site initiation for various protocols
• Provide inputs in site selection process for various protocols
• Coordinate 4 DRTB (Drug Resistance to Tuberculosis) study sites from H.O., New Delhi
• Update site details to Project Manager (PM) regularly
• Attend meeting with PM and HOD regarding progression of subject recruitment
• Motivate investigators (total:21) through telephone according to company requirement
• Provide inputs related to protocol and CRF design
• Perform monitoring 4 DRTB study sites in accordance with monitoring plan
• Build relationship with investigators and site staff
• Look for compliance with Protocol, Regulatory requirements and protection of subject
rights, safety & wellbeing
Number of Reportees: 04
I have been promoted as Senior Clinical Research Executive since Oct” 2009
4. • Worked as Clinical Research Coordinator (CRC) for Apothecaries Foundation, New
Delhi, from 14th
May 2008 to Oct 2009. Handled Narcotic projects (Oncology) at Indo-
American Cancer Institute and Research Center, Hyderabad.
Work Experience at Satyam BPO (Pharmacovigilance):
Worked as Health Care Professional Assessor in Pharmacovigilance at Satyam BPO Ltd from
June 26, 2007 to September 2007.
Work Experience at Apollo Hospitals (Clinical trials):
Worked as Clinical Research Coordinator at Apollo Hospitals Educational and Research
Foundation (formerly Spectra Clinical Research Center), Apollo Health City, Jubilee Hills,
Hyderabad, from Jan 2006 to July 2007.
Professional Skills and Strengths:
• Very good experience in Clinical Research over 3.6 yrs
• Sound knowledge on ICH-GCP guidelines, Schedule Y, Regulatory environment
and Safety reporting (Pharmacovigilance)
• Trained on Six Sigma Green belt at TechMahindra from 27 to 31Jan2014
• Well experienced in working on e - CRF
• Well planning, organizing and leading team
• Well discipline, decision making, flexible, proactive, ability to cope under pressure
and good eye for detail
• Find and resolve problems
• Always eager to learn new things
• Production of quality with quantity of work in time
• Consistent performer with hard work
• Innovation and creation towards organization Mission and Vision
• Prohibition and avoid repetition of work & interpersonal misunderstanding
• Implementation & development of standard operating procedures
• Very good business communication (verbal and written)
• Very good knowledge of conducting feasibility, site selection, site initiation,
monitoring and close out activities
• Good presentation and documentation skills
• Result oriented, dedicated, hard working, punctual, helping and friendly nature.
• Very good team tasks shall play in different situations
Educational Qualification:
B. Pharmacy: Completed in Jun’2005 at S.S.R. College of Pharmacy under Osmania
University, Andhra Pradesh.
M.B.A (Project Management):Completed in Mar’2011 at Sikkim Manipal University.
Certification training:
· Certified on “Oracle Argus Enterprise Edition 7 PreSales Specialist” and
“Oracle Argus Enterprise Edition 7 Sales Specialist”.
· I have attended/trained workshop on ICH-GCP guidelines at Nizam’s institute of
medical sciences, Hyderabad conducted by QUINTILES Research India (Pvt.)
Ltd, Bangalore.
5. · I have been trained on ICH-GCP guidelines at Apollo Hospitals Educational and
Research Foundation, Jubilee Hills, Hyderabad conducted by SIRO clinpharm,
Mumbai.
· I have attended Apothecaries Knowledge Management Program conducted by
Clinical Research Academy from 29th
May 2008 to 31st
May 2008
Achievements:
• Received Associate Consistently Excel award on 23Apr2014 for consistent
performance consecutively for two years (2012 and 2013)
• “Consistent performer” among all Research Coordinators with respect to quality and
quantity of work in Narcotic Oncology Projects at Apothecaries Pvt. Ltd., New Delhi.
• Got “appreciation” for dedication, hard work and consistent performance in Narcotic
Oncology Projects at Apothecaries Pvt. Ltd., New Delhi.
Member of professional bodies:
REGISTEREDPHARMACIST of Andhra Pradesh Pharmacy Council of India with
registration no. of A1 045297.
Personal Data:
Father’s Name : Jinugu Gopaiah
Date of birth : 10th July 1982
Languages known : English, Hindi, Telugu
Marital Status : Married
Nationality : Indian
Contact address : H. No: 13-9-1/3/4,
Radhakrishna nagar, Borabanda
Hyderabad- 500080
Telangana, INDIA.
SWAMY JINUGU
Reference:
1. Mr. B. Rajesh
Manager- Pharmacovigilance
Inventive Healthcare Limited,
Hyderabad, India
Mobile: 9985 644 940
2. Dr. Antaryami Maharana
Drug Safety Physician - Pharmacovigilance