www.clarislifesciences.com Claris Lifesciences Ltd Ahmedabad : Pharmacovigilance Manager

[Admin]

Claris Lifesciences Ltd Ahmedabad : Pharmacovigilance Manager
Website : http://www.clarislifesciences.com
clarislifesciences.com

About us :
Claris Lifesciences is one of the largest sterile injectables pharmaceutical companies in India with a market presence in 76 countries worldwide. We primarily manufacture and market products across multiple markets, and therapeutic segments. A significant majority of these products are generic drugs that are capable of being directly injected into the human body and are predominantly used in the treatment of critical illnesses.

Our products range across various therapeutic segments, including anaesthesia, critical care, anti-infectives, renal care, infusion therapy, enteral & parenteral nutrition and oncology. We offer injectables in various delivery systems, such as glass and plastic bottles, vials, ampules, pre-filled syringes and non-PVC/PVC bags.

Asst. Manager – CQA
Job Description :
1. Complaint handling
2. Internal quality audits
3. Facilitating regulatory audits
4. Pharmacovigilance
5. Annual product review

Qualification : B.Pharm / M.Sc. (Bio-Chemistry, Chemistry, Microbiology)
Experience : 7 - 8Yrs.
Desired profile :
Candidate should have worked in corporate QA function of a regulated plant. Should have understanding of injectable manufacturing process. Should be conversant with international regulatory guidelines.

Location : Plant near Ahmedabad

Contact us :
Claris Lifesciences Limited
Claris Corporate Headquarters
Nr. Parimal Crossing, Ellisbridge,
Ahmedabad - 380 006,
India.
Tel : + 91-79-26563331

[Guest-IJT]

Curriculum Vitae
Kushan Patel (B.Pharmacy Honor’s)

Objective : Seeking for the position of Clinical Research Associate in the medical field while merging into a globally focused organization that will purposefully utilize my qualifications while offering several opportunities to integrate personal enrichment with professional goals.

Personal Details :
Name : Kushan Dhirajlal Patel
E-mail : patelkushan35 AT gmail.com

Skills :
- Able to work under optimal supervision
- Excellent organization, planning and problem solving abilities.
- Excellent negotiation and analytical skills.
- Established interpersonal and communication skills.
- Fluent in English and other local office languages both verbal and written.
- Proficiency in computer.
- Able to work effectively and efficiently in a matrix environment.
Work Experience :
- Company : Synchron Research Services Private Limited
- Duration : Since July 2008.
- Position : Clinical Research Associate-I.

Roles & Responsibilities :

- To support the clinical trial team with ongoing conduct of studies.
- Tracking of feasibilities by allotting and conducting and managing.
- Conducting Site qualification/selection visits for new studies.
- Conduct the Site Initiation Visit, the Site Monitoring Visit, follow up of enrollment, Site Closure for Clinical trials.
- Setting-up, tracking and maintaining audit documentation and study status in clinical trial operations.
- Managing and tracking regulatory, Ethics Committee documentation and other clinical trials documents on paper as well as electronically.
- Creating and maintaining Project and/or Site Specific Files.
- To assist clinical project management team with study specific documentation as appropriate (preparing study-specific procedures, drug accountability records, completion of status reports study newsletters and merge letters).
- To assist in the preparation, handling and tracking of Ethics/Regulatory Affairs submissions.
- To co-ordinate in ordering/dispatch and tracking of clinical research materials e.g. CRFs, diary cards, lab supplies, drug supplies as appropriate.
- To review translated documents.
- Keep the Head Clinical Operations informed of any issues within the Clinical Trial team which require attention.
- To explore the possibilities of new study sites and perform Identification and selection of the trial sites and Investigators.
- Submit the feasibility report to the Clinical Trial Head within appropriate timelines.
- Coordinating with the Clinical Trial Head and to inform on regular basis about the progress of the trials.
- Organizing and conducting Clinical Trial operations team weekly meetings.
- Database maintenance of Clinical Investigators for future references.
- Review and manage day to day activities of CTO team.
- Review of Routine monitoring visit reports and follow-up letters prepared by CRAs for studies.
- Training of new employees of Clinical Trial Team.
- To Guide Grade-II CRAs in day to day activities and site issues. .
- To provide inputs in construction of protocols, CRFs and ICFs.
- To design Monitoring manual for the study.
Educational Qualification :

Course University Year Class
B. pharmacy Rajiv Gandhi University of Health and Sciences, Bangalore 2006 1st class
Fifth year in Clinical Research Nirma University, Ahmedabad 2008 Distinction

Training and seminar attended.
- Attended Training on Essentials of ICH GCP & Schedule Y by Consortium Clinical research Pvt.Ltd.

- Attended Training on Clinical Research monitoring by Consortium Clinical research Pvt. Ltd.

- Trained on Good clinical practice (GCP) by various CROs and Pharmaceutical Companies.

- Training on Protocol Designing & Writing.
- Attended Investigator’s meetings.

- Attended training for PHEEDIT.
Computer literacy :
- Microsoft Office.
Declaration : I hereby declare that the above mentioned details are true and correct to the best of my knowledge.


Yours faithfully,
Kushan Patel.

[Guest]

CURRICULUM VITAE
Akhila Kumar Das
Email- das.akhila AT gmail.com , das_akhila AT yahoo.com
Odisha State Pharmacy Council Registration No- 10144 (Registered on 11th September 1998)
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CAREER OBJECTIVE
To work with one of the best establishment which provides a good work environment & opportunity to grow in professional career as a good Pharmacist.
PROFESSIONAL QUALIFICATION
M.PHARM(Pharmacology),2009 : Passed 1st semester with 1st class, SGPA 9.08
Passed 2nd semester with 1st class, SGPA 9.36
Passed 3rd semester with 1st class, SGPA 9.50
Passed 4th semester with 1st class, SGPA 9.00
CGPA 9.14
Project Work :Neuroprotective activity of Rosuvastatin in CA1 & CA3 subfield of hippocampus in Pilocarpine induced Status Epilepticus
(From School of Pharmaceutical Sciences, SOA University,BBSR.)
B.PHARM,1997 :Passed with 1st class (71.94%)
Project Work : Synthesis of 3-substituted Indole-2,3-dione derivatives as potential antidepressant effect
( From Sri Jayadev College of Pharmaceutical Sciences, BBSR.)
EDUCATIONAL QUALIFICATION
+2 Science (1993) :Passed with 1st class (75.55%)
(From Stewart Science College,Cuttack.)
H.S.C (1990) :Passed with 1st class (80.43%)
(From Basudev high School,Gopapur.)
INDUSTRIAL TRAINING
Milton Chemicals, Cuttack,
Designation- Trainee Chemist
Duration- 15.02.1998 - 15.09.1998
(In both Production and Quality Control department )
HOSPITAL EXPERIENCE
Sarala Nursing Home, Emporium Lane, Cuttack.
Designation- Pharmacist
Duration- 15.09.1998 - 30.04.01
MARKEING EXPERIENCE
1.Ajanta Pharma Ltd, Mumbai, (INDIA)
Designation- Medical Representative
Duration- 01.06.2001 - 11.10.01
2. East African India Remedies Pvt. Ltd, New Delhi, INDIA
Designation- Marketing Executive (Regional Manager)
Duration- 11.10.2001 - 26.07.05
TEACHING EXPERIENCE 1. Women’s Polytechnic (Orissa Govt.)
Designation- Resource Person
Duration- 26.07.05-14.11.08
2. Viswas College of Nursing, Bhubaneswar.
Designation- Visiting Faculty (Pharmacology)
Duration - 20.06.06 -31.08.09
4. IMT Pharmacy College, Gopalpur, Puri.
Designation- Lecturer (Pharmacology)
Duration- 01.09.09 – 13.09.2010.
PHARMACOVIGILANCE EXPERIENCE
Presently working in Pharmacovigilance Programme of India (PvPI) at Zonal Office of Central Drugs Standard Organisation, Govt. of India. From 13th September 2010.
REFRESHER COURSE ATTENDED
- 10th UGC Refresher Course in Pharmaceutical Sciences organized by Department of Pharmacy, Annamalai University, Annamalai,Tamilnadu. Duration : 3 weeks (Jan-Feb 2007, 24.01.07-13.02.07)
- Induction Training Program held in Women’s Polytechnic, Bhubaneswar
Organized by Technical Teachers’ Training Institute, Kolkata Duration : 5 days (18.01.06-22.01.06)
COMPUTER KNOWLEDGE
MS Word, Excel, Power Point, Data entry into vigiflow software.
ACHIEVEMENTS
- Qualified written test for Drugs Inspector twice (in 2003 & 2004) conducted by Orissa Public Service Commission (OPSC).
- Qualified written test for Pharmacist in Central Rice Research Institute (CRRI), Orissa.
- Utkal University Topper in B.Pharm.
- SOA University 4th position in Pharmacy.

[naimishghodasara]

Respected all,
I Naimish Patel pursuing M.Sc. in Pharmaceutical regulatory affairs at Manipal university Department of Advanced pharmaceutical sciences. In my 1st semester curriculum i studied about most of the guidelines and Act of USFDA such as ANDA, IND, NDA, accelerated drug approval process, bio-research monitoring, labeling requirement, advertisement, CTD format and in another subject i studied about Indian guidelines and Act for approval, import and export of drugs.
Currently i am studying in 2nd semester of this course and it will cover all the ICH guidelines for Quality, Safety, Efficacy and multi - disciplinary, pharmacovigilance aspects.

In my 3rd and 4th sem i hv to do one major project on any title which is related to pharm. regulatory affairs and will be more beneficial for future.
So, i kindly requesting you all to suggest me best topic for my project work. I hope you will respond me as soon as possible.
Regards
Naimish

[Guest]

I have completed M.Com. If any suitable job in your company,please inform me.