Novartis Healthcare Pvt Ltd Hyderabad : Clinical Safety Team Leader

[deepika]

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.

Designation: Clinical Safety Team Leader

Job Description
1. Manage and lead his/her team and ensure that all tasks are performed according to business rules, guidelines and standard operating procedures; Monitor workload and allocate resources appropriately.
2. Ensure the development of processes and procedures to meet global safety reporting requirements and the management of incoming adverse event reports.
3. Maintain high level of compliance for processing of incoming adverse events reports by the team according to internal timeframes and Health Authorities requirements.
4. Communicate achievements, issues and actions regularly with global management
5. Set up yearly objectives and review performances of team ensuring best use of available re-sources. Discuss and set up development plans with/for all team members to further develop individual's skills and potentials.
6. Facilitate training for new hires according to the individuals' experience and needs.
7. Review entered case reports and monitor the quality of work produced by the team and implement quality improvement initiatives as appropriate.
8. Alert global management to potential safety signals based on incoming case reports
9. QC periodic regulatory safety reports before submission to management approval and ensure compliance with required timelines.
10. Promote working relationships between Integrated Medical Safety and other groups such as; other members of Integrated Medical Safety, medical personnel, Clinical Data Management, Clinical Research, Marketing.
11. Play an active/leading role in cross-functional teams on safety matters/ Integrated Medical Safety special projects relating to investigational and marketed drugs.
12. Facilitate the training of other departments in clinical safety related procedures/regulatory obligations.
13. Support and work closely with manager to set group strategy and achieve group objectives

Desired Profile
Medical degree (MD)/MS in Clinical Pharmacy/PhD in life sciences or related fields
Excellent oral and written English skills
At least 4 years experience in pharmaceutical R&D, including at least 2 year in clinical safety or closely related areas of development
At least 3 years management experience with demonstrated leadership skills

Experience 7 - 12 Years

Contact
Novartis Healthcare Pvt Ltd
Telephone 9885277583

http://www.novartis.com

[Guest-IJT]

Res/sir,madam,
I take this opportunity to introduce my self as a suitable candidate for your esteemed organization as for as my qualification is concerned. I completed my MSc Micro Biology from KAKATIYA UNIVERSITY (2009).

I am sure if suitable opportunity will be given to me to prove my worth. I assure you that I will fulfill your requirements in a best possible manner.

Curriculum Vitae
K.S.N.PRAVEEN
Mobile No:- 9177384212
E-Mail:- Praveensainu17 AT gmail.com
Praveen_sainu17 AT yahoo.com.

Objective:-
Looking forward to work in an Organization that offers a challenging environment to work in and provide scope for individual development and offers attractive prospects for Long-Term Personal Development and Career Growth.

Job Objective:-
Seeking responsible & suitable position in R&D/QC/QA.

Educational Qualification:-
Ø S.S.C ( 74.5% )from Sri Vani Vidhya Niketan High School.
Ø INTERMEDIATE from Narayana Junior College (2002-04). COURSE Bi P C ( 70.1%)
Ø GRADUATION ( 69.1% ) from OSMANIA UNIVERSITY(2004-07).
Optionals BIO – TECHNOLOGY ( 69.3% )
MICRO – BIOLOGY ( 67.8% )
CHEMISTRY ( 70.1% )
Ø POST GRADUATION from KAKATIYA UNIVERSITY (2007-09). M.Sc MICRO – BIOLOGY (66.4%)

Other Qualification:-
Ø Done the Basics of Computer (MS OFFICE).
Ø Technical qualification - Typing (LOWER).

Key Skills:-
Ø Energetic
Ø Ability to work in a Team

Strengths:-
Ø Strong will to achieve multiple tasks.
Ø Maintaining a good interpersonal relationship.

Personal Profile:-
Name : K.S.N. PRAVEEN
Present Address : H:No:- 12-10-652/1, Indira Nagar
Warasiguda , secunderabad.
Pin : 500 061
Sex:Male
Date of birth:17th August, 1987
Father’s Name : K.Yadagiri
Marital Status:Unmarried
Languages Known :English, Hindi & Telugu

Declaration:-
I here by declare that the information provided above is true and correct to the best of my knowledge.

Date:- 26/08/2009

Place: - Secunderabad (K.S.N. PRAVEEN)

[Guest]

Dr Sheetal A. Rothe
Email Address : sheetal.rothe AT gmail.com
Qualification : B.A.M.S. (2001 july-2007 feb)
C.G.O , C.C.H. (Royal Institute of medical continuation, Mumbai)
M. D. Rasashastra (Aug 2008-july 2011) from National Institute of Ayurveda , Jaipur
Experience : Internship 2006-2007 (1year)
As a assistant doctor in Sawarkar Maternity Hospital , Amravati (feb 2007- july 2008 – 1year & 5 months)
Resident doctor : N.I.A jaipur (Aug 2008 to present – 2years & 10 months)

Awards - “Jeevak Award “ from Himalaya Drug company For college Toppers.
- “Best Intern Award- 2006-2007” from SGAC college Amravati
- “Dr Jaiswal Smriti Puraskar” from SGAC college Amravati

[vanarchi.ragini]

hello sir this is ragini and here is my cv which describes about my qualification

[Guest]

CURRICULUM VITAE
M.VANI
Email ID : vani29785 AT gmail.com

CAREER OBJECTIVE
To pursue a challenging career in the field of Pharmacovigilance in a progressive way that gives me scope to update my knowledge and skills and to be a part of the team that excel in work towards the development of the organization and gives me satisfaction there of.

ACADEMIC QUALIFICATIONS
- Completed PG Diploma in Clinical Research and Pharmacovigilance from GITS Academy (Bangalore, Karnataka), 2012
- Completed M. Pharmacy (Pharmacology) from Vaagdevi College of Pharmacy, Warangal, KAKATIYA UNIVERSITY, during the period 2007- Jan 2010, with an aggregate of 72 %.
- Completed B. Pharmacy from Sarojini Naidu Vanita Pharmacy Maha Vidyalaya, Hyderabad, OSMANIA UNIVERSITY, during the period 2003-2007, with an aggregate of 77 %.
- Completed Intermediate (M.P.C.) from New Generation Junior College, Khammam, during the period 2001-2003, with an aggregate of 94.2 %.
- Completed S.S.C from Chaitanya Grammer School, Kodad, during the period 2000-2001, with 84.1 %.
ACHIEVEMENTS :
- Secured All India Rank 1425 in GATE exam held in 2007.
- Secured State 26th Rank in PGECET exam held in 2007.
PROFESSIONAL EXIPERIENCE
Jun 2007-Oct 2007 : Researcher
Datamonitor,
Hyderabad.
Oct 2010- May 2010 : Clinical Research Coordinator
Bangalore Clinisearch,
Bangalore.
PROJECT WORK
“Studies on Antihyperglycemic activity and Glucose uptake mechanism of ethanolic extract of Lannea coromandelica bark, Ellagic and Boswellic acids” a part of fulfilment for the award of degree of MASTER OF PHARMACY in PHARMACY.
SEMINAR PRESENTATIONS
- Presented a seminar regarding “Drug Interactions” at Vaagdevi College of Pharmacy, Hanamkonda.
- Presented a seminar on “Role of Renin Angiotensin System in regulating BP” at Vaagdevi College of Pharmacy, Hanamkonda.
TECHNICAL SKILLS
- In-depth knowledge in Pharmacovigilance
- Good understanding of ICH E2 (A-F) Guidelines
- Knowledge of PSUR, PADER, ASR, DSUR
- Reporting elements for SUSAR, ICSR
- Knowledge in Clinical Research
- Good understanding of ICH-GCP, Schedule Y, 21CFR Part312, 21CFR Part314
- MS Office - Word, Power Point, Excel and Access
PERSONAL SKILLS
- Excellent communication skills
- Self-motivated and result-oriented
- Excellent interpersonal and conflict resolution skills
- Excellent attention to detail
- Ability to work individually and as part of a team achieve short- and long-term goals
- Excellent time management skills
DECLARATION :

I hereby declare that the details furnished above are true to the best of my knowledge.

(M.VANI)
Signature of the Candidate

[Guest]

I have completed my M. Pharma in Pharmacology and searching job as a Pharmacovigilance officer in an IT Company. Please help me regarding this.

[Guest]

Bhawna Khaneja
bhaw_khaneja AT yahoo.co.in
Profile
- Competent, diligent & result oriented professional, offering 4 plus years of extensive cross-functional experience in successfully & consistently delivering the responsibilities.
- Motivated, high-energy educator with demonstrated track record in fostering student learning.
- Successfully developed and conducted training programs facilitating professional growth & development of the staff hence resulting in higher levels of employee satisfaction, retention rates and increased efficiency & profitability
Professional Experience
Career Summary
Apr 2012 - ongoing Chief Pharmacovigilance Specialist at Quantum Solutions India
Nov 2010 - Mar 2012 Senior Quality Analyst, Quantum Solutions India
April 2010 - Oct 2010 Senior Quality Scientist, Quantum Solutions India
Nov 2009 - Mar 2010 Quality scientist, Quantum Solutions India
July 2008 - Oct 2009 Pharmacovigilance scientist, Quantum Solutions India
Professional Knowledge/ Research Experience
- Management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programmes) which includes :
- triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities
- initiation of ICSRs into the safety database
- conducting duplicate searches prior to initiation and identifying potential duplicates
- managing duplicate couples/cases appropriately
- coding of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents (such as SPC, CDS, IB etc.), writing case summaries, assessing causalities if required and writing Company comment if required
- data validation i.e. cross checking against source documentation.
- Expertise in MedDRA coding in accordance with “MedDRA Term Selection : Points to Consider”
- Expertise in managing safety data on various safety databases
- Maintaining an excellent knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including
- ICH guidelines on safety and efficacy
- Volume 9a
- FDA guidelines
- CIOMS
- Coded over 3500 cases till date.
- Handled 225+ cases and 300+ studies
- Worked on old cases, project, reconciliations
- Experience in the following therapeutic areas :
- Oncology
- Infections and Infestations
- Dermatology
- Cardiovascular
- Rheumatology
- Immunology/Autoimmune Diseases
- Metabolic disorders
- Hematology
- Virology
- Psychiatric and CNS Disorders
- Expertise in :
- report nullification (decision making and processing) and case merging into a ‘Master’ case
- reconciliation of safety and clinical databases
- clinical narrative writing
- end of study blind break plan writing and processing
- working with E2B cases received from business partners
- literature case review and coding
- Literature experience :
Have experience in review and validity assessment of articles, triage, duplicate searches, registration, MedDRA coding, AE text writing, QC of literature (both clinical and spontaneous) reports, Query identification and tracking, Addition of company comment
- Maintaining awareness of global regulatory reporting obligations and organizational workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
- Participated in various client audits.
- Expertise in handling the ERP systems (enterprise resource planning)
Quality experience :
- Quality Control/Quality Review : performing quality review of ICSRs to ensure high quality of the safety reports in accordance with client SOPs and regulatory requirements.
- Preparing quality matrix for the reviewed ICSRs and correlating the degree of accuracy in ICSR coding.
- Guiding and conducting training for the drug safety associates on different levels of case coding so as to ensure a high degree of accuracy and quality.
Duplicate Detection for regulatory authority :
- Identifying potential duplicates in the Eudravigilance database for regulatory authority.
- Processing of duplicates and informing the regulatory authority for the duplicate case reports.
- Querying the competent authorities, MAHs and pharmaceutical companies for additional information on individual case safety reports.
- Quality review of randomly selected individual case safety reports in accordance with the regulatory authority SOPs and work instructions.
- Preparation of quality matrix for drug safety associates and conducting ad-hoc training on various aspects of duplicate detection as per the regulatory authority specifications.
Periodic Safety Update Reports and Drug Safety Reports :
- Extensive experience in periodic safety data reports including PSURs, case narratives of PSURs, addendum reports and Summary Bridging Reports across multiple clients.
- Handling responsibility for preparation of aggregate reports in accordance with customer conventions or guidelines and SOPs including triage and summarization of literature search result and inclusion in aggregate case report.
- Completes and ensures completion of signal detection related projects/reports including DSR and Medical Evaluation assessment group in accordance with customer requirements.
Query management :
- Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with clients’ policies
- Sending queries to ensure timely regulatory completion of frontloaded narrative writing in clients' database for PSUR
- Responding to clients/customers in a timely manner
Thesis Work
- Potential of lactonases as quorum quenching enzymes and their applications.
Training
- “Antibiotic Susceptibility of Lactobacillus sp. isolated from common Indian dairy products” at Thapar Institute of Engineering and Technology, Patiala
Seminars Delivered
- Laccases-versatile enzymes
- Yeast to Hybrid Technology
- RNA interference and its applications
- DNA footprinting and its applications
- Influenza Vaccine
- Enzymes and procedures involved in starch processing
- Ion Exchange Chromatography
- Probiotics and their benefits
Technical skills
- Basic Microbiological Techniques
- Bio-Analytical Techniques
- Molecular biological techniques
Management Skills
- Handling the task of updating the team regularly as per the requirements of the management
- Managing and dividing the task in contingent work situations
- Being consulted by the management in meeting the project deadlines
Computer skills
- Well versed in Microsoft Word, Excel, Power Point, C language, Internet and Web Designing (HTML, DHTML, Front page, Page Maker, CorelDraw, Adobe Photoshop).
Other Key Achievements
- Topper in Masters of Mass Communication (MMC) - 1st year examination (2010-2011)
- Qualified the GATE entrance examination in the year 2005-2006
- Topper in B.Sc (H.S.) II and III year
- Topper in 12th standard examinations in I.C.L. Public School
- Served at the post of Vice-President of Department of Microbiology, Panjab University for the year 2007-2008
- Served at the post of Department Treasurer in Department of Microbiology, Panjab University for the year 2006-2007
- Served at the post of General Secretary of Department of Microbiology, Panjab University for the year 2005-2006
- First Prize winner in basketball match at the microbiology sports meet in the year 2006-2007
- First Prize winner in basketball match at I.C.L. Public School in the year 2001-2002
- Participated in various inter-school debates, declamation contests, science quiz and one-act plays
Educational Qualification
- 2010-2012 - Masters in Mass Communication (MMC) from Guru Jambheshwar University of Science and Technology, Hisar; result awaited for 2nd year
- 2006-2008 - M.Sc (H.S) from Department of Microbiology, Panjab University, Chandigarh
- 2003-2006 - B.Sc (H.S) from Department of Microbiology, Panjab University, Chandigarh
- 2001-2002- 12th class from I.C.L Public School, Rajpura
- 1999-2000 - 10th class from I.C.L Public School, Rajpura
Seminars/Conferences Attended
- Attended Symposium on “Microbial Boons- Challenges Ahead” held at PanjabUniversity, Chandigarh on October 23, 2007
- Attended “Microcon-(NW) - 2007, Indian Association of Medical Microbiologists, North-West Chapter” held at Dayanand Medical College and Hospital, Ludhiana on October 6, 2007
- Attended Indo-US Symposium on “Stem Cell Identification and Characterization : Role of Molecular Markers” held at Panjab University, Chandigarh on February 8, 2007
- Attended National Symposium on Advances in Biotechnology held at Sanatan Dharma College, Sector 32-C, Chandigarh on February 3, 2007
Personal Skills
- Always achieving the required target well ahead of scheduled timeframe. Workaholic by nature.
- Believes in submitting high degrees of quality and standards
- Getting regular appreciation for work quality and compliance
Other Skills/Interest/Hobby
- Good Communication skills
- Fluency in writing and spoken English
- Reading books, newspapers, cooking, art and craft
- Head girl and sports captain while in school