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Showing posts with label Pharmacovigilance. Show all posts
Showing posts with label Pharmacovigilance. Show all posts

Wednesday, 26 October 2016

Job Description


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  • End to End Case processing in Safety database (Argus)/ application including Case Narrative writing/ medical writing in accordance with source data. 
  • Processing of Spontaneous, regulatory, clinical trial and literature cases/ all type of case reports
  • Seriousness and Listedness (expectedness/ event labeling) assessment
  • Coding of events, drugs, medical history and lab test as per MedDRA & WHO dictionary.
  • Reconciliations of records

Thursday, 20 October 2016

The Indian Pharmacopoeia Commission (IPC) is an Autonomous Body under Ministry of Health & Family Welfare, Govt. of India primarily with the objectives of regularly updating the Indian Pharmacopoeia by publishing new edition and its addenda, National Formulary of India and other related tasks such as preparing, certification and distribution of reference substances & functions as National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI).
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Application is to be submitted to the AMC Co-ordinator (Dr. Sachendra K. Srivastava), 
Department of Pharmacology,
Surat Municipal Institute of Medical Education & Research,
Ring Road, Near Sahara Darwaja,
Opposite Bombay Market, Umarwara, Bharat Nagar, Surat-395010.


Wednesday, 19 October 2016

Job Description

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Walk-In Event for Pharmacovigilance role for Mumbai Location :-


Job Responsibilities :-
  • Working knowledge on Med DRA
  • Track all adverse event reports received and completed
  • Review and assess all source documents, and compile data in an adverse event report
  • Data enter report into the client safety database
  • Code adverse events in the client safety database
  • Release report to client through client safety database
Walk-In Details :-

Work Location :- Mumbai

Job Description

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    Performs Pharmacovigilance activities for all assigned Novartis projects or products including identifying and analyzing safety signals based on a comprehensive evaluation of post-marketing data and Serious Adverse Events (SAEs) from clinical trials.
    1.Monitors the clinical safety of projects/products and responds appropriately
    2.Performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, and preparation of investigator notifications. Medical review of single case reports will be performed by associates possessing medical degree.
    3.Identifies safety signals based on the review of solicited or unsolicited single cases and confirm that they are not overlooked. Performs signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools.
    4.Provides input into responses to inquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues.
    5 Provides Pharmacovigilance input to initial development of basic prescribing information and is responsible for Pharmacovigilance input into updates of this information.
    6.Prepares medical input to aggregate clinical safety regulatory reports
    7.Provides input to safety profiling and risk management plan
    8.Provides guidance as appropriate to Clinical Safety Operations for the coding and causal- ity/expectedness assessment of adverse event reports.
    9.Provides expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on Novartis drugs.

Friday, 7 October 2016

Job Description

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The Manager Scientific WritingPharmacovigilance needs to lead and manage delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards for deliveries made by the medical writing group, including scientific documents and clinical/medical reports. He or she contributes to overall quality enhancement by ensuring high scientific standards for the output produced by the medical writing group through expert review and feedback mechanism to the delivery teams.

Job Description:

The roles and responsibilities of the Manager Scientific WritingPharmacovigilance include the following:

Developing scientific medical content for all projects that meet international quality standards

Interfacing with clients on a regular basis to meet their expectations

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics - ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Post : Pharmacovigilance - Freshers

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Candidate Profile : 
Mpharm /Bpharm/M.Sc(Lifescience)/B.E(Biotech).
Additional Information:
Experience : 0 years
Qualification : B.pharm / m.pharm/B.E/M.Sc
Location : Bangalore
Industry Type :  Pharma / Biotech / Clinical Research
Functional Area :Pharmacovigilance
Interview Date- 6th and 7th of October 2016.
Reporting Time-9 AM
Venue: Quintiles Technologies India Pvt. Ltd.
Prestige Technology Park II,
Etamin Block (Building B3),
Sarjapur-Marathalli Outer Ring Road,
Bangalore – 560103

Job Description


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    Dear Candidate,

    Wipro BPS is Hiring for Pharmacovigilance Business.

    - CANDIDATE SHOULD BE COMFORTABLE FOR VOICE PROCESS

    - CANDIDATE SHOULD BE OKAY FOR NIGHT SHIFTS & REGISTERED PHARMACIST.

    Please find the JD below, if interested please walk-in to the below address with the required documents.

    Interview Address:

    Wipro,A- 23, Mathura Road, Sarita Vihar, Near Sarita Vihar Metro Station, New Delhi - 44 

    Walk-in Date: 7th Oct , 2016(Friday))

    Walk-in Time: 11am - 4pm
    Apply now

Thursday, 6 October 2016

Job Description

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    Dear Candidate,

    This is to keep you informed that, Quintiles is hiring for Pharmacovigilance role . Walk-in on October 15th 2016 from 9AM on-wards.

    Job Location-Bangalore

Tuesday, 4 October 2016

Job Description

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    Looking for  Pharmacovigilance Writer

    Required

    PSUR

    DSUR

    PADER

    PBRER

    Aggregate Report Writer
    Company Profile:
    Kelly Services India Pvt. Ltd.

    Leading CRO

Friday, 30 September 2016

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Post: Pharmacovigilance

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Wednesday, 28 September 2016

Job PURPOSE  
Good communication skills
Good interpersonal skills and good attitude
Good knowledge in Pharmacovigilance(case processing and drug safety)


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If interested kindly send your updated resume to my email id- roshini.y@quintiles.com

Tuesday, 27 September 2016

Job Description

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    Dear All,

    We are pleased to inform you that we have multiple positions opened for Pharmacovigilance.

    Experience - 2 to 8 years
    Skills Required - Case Processing
    Job Location - Bangalore
    Date & Time - 1st October 2016

Monday, 26 September 2016

Job Description

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    Dear All,

    We are pleased to inform you that we have multiple positions opened for Pharmacovigilance.

    Experience - 2 to 8 years
    Skills Required - Case Processing
    Job Location - Bangalore
    Date & Time - 1st October 2016

Saturday, 24 September 2016

It is a Fortune 500 company and the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 32,000 employees conducting business in approximately 100 countries
Post: PV-Operation Specialist

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Walk in interview Date : 24th September, 9:00 am at Prestige Technology Park II, Etamin Block  (Building B3), Sarjapur-Marathalli Outer Ring Road, Bangalore – 560103

Friday, 23 September 2016

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics - ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Post : Pharmacovigilance - Freshers
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Job description
good communication skills, interpersonal skills, good in technical knowledge (Pharmacovigilance)


Interview Date-24th September 2016 
Reporting Time-9 AM
Venue: Quintiles Technologies India Pvt. Ltd.
Prestige Technology Park II,
Etamin Block (Building B3),
Sarjapur-Marathalli Outer Ring Road,
Bangalore – 560103
Job Description   

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Manage and lead processing team, liaising with CPO and third parties and ensure that all tasks are performed according to business rules, guidelines and standard operating procedures. Monitor workload and allocates resources appropriately. Ensure that incoming Adverse Events are processed by the team according to internal timeframes to meet Health Authorities requirements. Monitor the quality of work produced by the team and support quality improvement initiatives as appropriate. Provide feedback to team members on quality and train team members as appropriate to improve quality. 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. 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. Support the training of other departments in clinical safety related procedures/regulatory obligations. Interact with the Medical Safety Physicians on project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports. Support the Medical Safety Physicians in monitoring the safety profile of a product. Represent DS&E at internal and external meetings. Work with external partner groups, e.g. co-licensing partners and Clinical Research Organizations to meet joint accountabilities. Ensure the development of processes and procedures to meet global safety reporting requirements and the management of incoming adverse event reports. Review, author and update SOP and support in global initiatives for ensuring enhanced quality and compliance. Involve in retention strategy and ensure associate engagement. Timely and high quality completion of safety administrator deliverables, according to established objectives. People development and managing attrition.



Apply here

Thursday, 22 September 2016

Job Description :

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  • Subject Matter Expert
  • Contribute to DS&E projects
  • Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents.
  • Author/co-author, along with Global Medical Safety Physicians, regulatory periodic safety re- ports (Periodic Safety Update Reports, US Periodic Reports) for Novartis mature portfolio: collecting, organizing, analyzing and presenting the data by means of DS&E templates and procedures.
  • Lead/co-lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing).
  • Review global marketing programs and establish process for AEs collection with global marketing teams.
  • Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of Pharmacovigilance commitments.
  • Collaborate with Electronic Data Management team to reconcile Serious Adverse Events be- tween the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database.
  • Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
  • Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and database, authoring or contributing to Product Specific Guidelines for assigned products.
  • Contribute to the preparation of Standard Operating Procedures and Argus processing conventions (MAP).

Friday, 16 September 2016

Open Walk-in for Freshers on 17 Sep'16- Pharmacovigilance

Quintiles
0 - 0 yrs
Bengaluru/Bangalore


Job Description


    Note : Candidates who have attended Campus Drive conducted by Quintiles are not eligible to apply

    Dear Candidate,
    We are pleased to inform you that we are conducting a walk In for freshers in Pharmacovigilance 17 Sep'16

    Reporting time : 9.00 AM

    Venue Details - Quintiles
    Etamin Block, Wing B, I floor
    Prestige Tech Park II, Outer Ring Road
    Sarjapur, Bangalore - 560103
    Landmark : Next to JPMC

    Candidate from Mpharm , Bpharm , DPharm , Msc Biotechnology , Btech Biotechnology , Mtech Biotechnology are preferred.

Thursday, 15 September 2016

Pharmacovigilance Physician @ Quintiles-only Mbbs/md Graduates

Quintiles
3 - 8 yrs
Bengaluru/Bangalore


Job Description

    Dear Candidates,

    1.Should be an MBBS/MD Graduate with 3 + years of Pharmacovigilance Experience .
    2.Good Communication skills.
    3.Flexible with shifts (6AM to 2:30PM / 2:30PM to 10PM)
    4.Ability to establish and maintain effective working relationships with cowokers, managers and clients.
    5.Adequate computer skills, especially Microsoft word, Excel & Powerpoint.
    6.Knowledge of Pharmacovigilance .


    Interested candidates can reach out at : Febin.M@quintiles.com


Company Profile:
Quintiles

Quintiles is the world's largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions - from pipeline through portfolio to population health รข„¢. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.  

Friday, 2 September 2016

Medical Surveillance Specialist - Quintiles

Quintiles
2 - 6 yrs
Bengaluru/Bangalore , Mumbai
Job Description
    Monitors, evaluates and analyzes laboratory results on a daily basis, from sponsor central laboratory. Laboratory safety parameters are monitored for each patient at every site throughout clinical drug trial

    Conducts preliminary review of laboratory results relative to established protocol-specific reference range guidelines, using relevant clinical laboratory experience.

    Maintains up-to-date laboratory knowledge via continuing education activities (i.e., completion of continuing education class, applicable QU courses, review of journal articles) or attendance at medical seminars

    To participate in various Pharmacovigilance procedures including the processing of Adverse Event (AE) reports through tracking, data entry, quality control, report generation and submission, records management, as well as other project related and system support tasks

    Based on clinical laboratory experience, identifies potentially significant trends or shifts in laboratory results and alerts Sponsor physicians

    To perform CEVA (Clinical Event Validation and Adjudication) project tasks in the areas of endpoint adjudication committee coordination, core laboratory coordination, DSMB administration, and Steering Committee administration

    Assist with Safety Reviews of Case Report Forms and Adverse Event and medical coding as requested
Company Profile:
Quintiles

Quintiles is the world's largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions - from pipeline through portfolio to population health รข„¢. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.  

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