Start your Pharmacovigilance Career- A stable and promising Career

Pharmacovigilance the drug safety it can be defined as the study and prevention of adverse effects caused by pharmaceutical products. Pharmacovigilance is the reason that many drugs are withdrawn from or not even brought into the market at times.
Our national health policy supports and helps to create more awareness about pharmacovigilance as their primary goal is to ensure students of medicine are aware of the adverse effects of certain pharmaceuticals. Pharmacovigilance makes it possible to implement quality systems in all pharmaceutical companies that manufacture large amounts of medicine.

Pharmacovigilance Courses

Training in pharmacovigilance is done by an expert international and national faculty with years of experience in the practical and theoretical aspects. All the study materials and course content are developed in a way that helps students to get the quality knowledge, exactly what is required to work into the industry as well as to prepare well for interview.

You may be eligible for a course in pharmacovigilance, if you are any one of the following:

• Graduate in Pharmacy and Bio-Sciences (final year students are also eligible)
• Medical Professional i.e Doctor of all disciplines
• Graduate in pharmacy and bio-sciences
• Junior professional in Pharmaceutical industry, IT Industry and Clinical Research Organisations.

Pharmacovigilance Salary

A job holder in this field can easily get the starting salary of Rs.3.5 - Rs.8 lakhs P.A..As more recognition is given to drug safety all over the world,jobs in India in this field are increasing in number. Hiring process are very much selective to candidates educational qualification, back ground knowledge, knowledge over drug development / pharmacovigilance area, communication skill and experience as applicable for different positions.

Pharmacovigilance Job Prospects

There is no shortage of jobs in this field as high-quality pharmacovigilance practice makes for good business dealing. Students in this field can get jobs in various pharmaceutical companies, bio-tech companies, medical device and IT Life Science KPO & BPO,Clinical Research Organisations (CRO), can earn attractive and handsome packages.With new drugs being made every day, a career in pharmacovigilance has promising prospects.

Pharmacovigilance Eligibility Criteria

To pursue a career in pharmacovigilance, the minimum eligibility criteria to apply for the program is:

• A postgraduate or graduate degree in Bio Science/Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech)
• A postgraduate or graduate degree with Chemistry as a subject
• A postgraduate or graduate degree in Pharmacy or Pharmaceutical Sciences, PharmD
• A postgraduate or graduate degree in Medicine

The selection process is based on merit.

Pharmacovigilance Scholarships

This program offers scholarship to every students based on merit. The Scholarship is offered based on the overall performance of the students from 10th level to last educational qualification examination (% of marks).

Pharmacovigilance Duration & Venue

The course takes student admission twice in a month . The first batch intake starts from 1st-10th of a month and second batch starts from 15-20th of a month.The number of admissions to each batch is limited, so that personal attention can be paid to each student, and this will also facilitate effective discussions and project oriented training during the course of study. Students and working professionals can do the program program from anywhere. Classes are in e-learning mode, where lectures will be provided over online environment in flexible timings (7-9am, 3-5pm and 8-10pm). Students can schedule their class day and time wise. Effective days of training are taken on the basis of no. of class.

Pharmacovigilance Fees

The total fees for 2 to 6 month course will be Rs.7,000 to 20,000 for working Indian Professionals and SAARC countries. The fees will cover all course materials, tution and examination fees.

Pharmacovigilance Examination

At the end of program students will be assessed on how well they have understood the course material. The exams will consist of:

• e-Exams written section consisting of multiple choice and semi-long question
• A Viva: 30 minutes long
• A short project to be submitted at the end of the course on the topics to be given by the Faculty on Pharmacovigilance

MORE ABOUT THE PROGRAM, FEES, DURATION and PLACEMENT ASSISTANCE.
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Clinical Trials -What is that?

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
An Institutional Review Board (IRB) reviews, monitors, and approves many clinical trials. It is an independent committee of physicians, statisticians, and members of the community. Its role is to

• Make sure that the study is ethical
• Protect the rights and welfare of the participants
• Make sure that the risks are reasonable when compared to the potential benefits

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Drug Safety Physician / Medical Reviewer - Synowledge PV Services India Pvt Ltd

JOB TITLE: Drug Safety Physician/ Senior Drug Safety Physician

LOCATION: Mysore, India

YEARS OF EXPERIENCE: 0-5 years experience in PV

EDUCATION: MBBS/ MD (Any)

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

As a Medical Reviewer

Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
Determine seriousness and relatedness across products as assigned
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
Acquire and maintain knowledge of applicable Global Health Authority regulations
Perform any other drug safety related activities as assigned
Participate in internal and external audits and inspections by clients and health authorities
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Openings for Freshers- Pharmacovigilance

Dear Candidate,

Looking for freshers who has completed their graduation B.Pharma/M.Pharma/ BDS/ M.Sc/B.Tech.

Quintiles is the worlds leading provider of biopharmaceutical services. With a network of 29,000 employees conducting business in approximately 100 countries, Quintiles has helped develop or commercialize all of 2013s top 100 best-selling products or compounds. Using our extensive therapeutic, scientific and analytics expertise, we help biopharmaceutical and health sciences customers navigate the increasingly complex landscape with more predictability to enable better outcomes.

RESPONSIBILITIES
Provide intake and tracking of initial safety and clinical event validation and adjudication (CEVA) data. Transfer incoming
safety/CEVA data to project team. Identify any problems with incoming faxes and bring them to the attention of the senior
team member.
Distribute safety data to marketing authorization holders, customers, regulators and investigators.
Specific project responsibilities include set-up and/or maintenance of safety/CEVA files for reported events; archiving of
files when closed; coordination of transfer of archived material to company/customer archive storage facilities;
preparation and assistance in setting-up and updating project files; maintenance of personal safety files for mail merges
and regulatory documents; where required, data entry of events into tracking database and assistance of transfer of
events to customers.
Provide administrative support for the department by coordinating team/department/customer meetings, coordinating
stationery orders, dispatching data via courier services, reserving meeting rooms and IT equipment; and providing
secretarial support as required.
Generate and distribute alert letters.
Identify and record quality problems and bring them to the attention of a senior team member.
Provide training/mentoring new/less experienced staff.
Assist project lead and CEVA management with specific aspects of CEVA processes.
Set up and maintain Serious Adverse Event (SAE) files for reported events; organize and send files for archive when
events are closed.
Coordinate, schedule and submit reports to regulatory authorities in accordance with deadlines.
Coordinate distribution of safety letters to study investigators and Clinical Research Associates.
Assist in processing incoming and outgoing Adverse Event (AE) reports by collecting and tracking incoming AE reports
sent via fax, email, eCRF, etc; determining initial/update status of incoming events; tracking timelines for completion of
AE processing; performing data entry into safety database; routing report information to appropriate PhV project
personnel in the workflow for continued processing; performing quality control activities as directed by project lead or
manager; generating established safety data reports; submitting AE reports to client and other project team members
identified by project lead; obtaining confirmation of report receipt and track submission; and assuming workflow
responsibilities for local and global projects.
Perform records management tasks such as creating and tracking case folders for AE reports; filing, retrieving and
delivering case folders; assisting in maintenance of document control room and relevant applications/systems as directed
by manager; archiving case folders and project files; assisting in creation of PhV records management processes and
procedures; providing key input to management on acquisition and/or upgrade of records management
application/systems; and serving as liaison between Pharmacovigilance department and records management
department.
Assist with system support tasks such as utilizing design specifications, AE form, and protocol, creating projectspecific
entry specifications and annotated AE forms for safety database with direction from project lead and/or manager;
creating project tracking spreadsheets and associated tracking entry specifications; assisting in database validation
through performance of user testing; performing ad hoc database searches for project team leads; assisting project lead
in assessing database setup needs; and assisting with assuring systems issues are reported and resolved.
Perform additional project-related and administrative tasks such as handling investigator mailings including creation of
labels using investigator list, copying of documents, envelope stuffing, and tracking and filing of submitted materials;
creating and maintain project files; working with project lead to develop project instructions; performing reconciliation
between the safety and clinical databases; distributing AE listings to client and/or project team members; performing
project start-up tasks; providing project metrics to management; and assisting with data entry, workflow and deadline
quality measurements.
Participate in continuous improvement of all departmental processes and procedures.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Basic knowledge of ICH and GCP
Basic knowledge of medical terminology if processing
Good understanding of Core Operating Procedures (COPs)
Word processing and data entry skills
Strong organizational skills and time management skills
Flexibility and excellent verbal and written communication skills
Ability to deal successfully with many internal clients competing for attention, services and resources
Good attention to detail and accuracy
Ability to establish and maintain effective working relationships with co-workers, managers and colleagues.
Highly motivated and organised with a flexible attitude
Ability to follow instructions/guidelines, utilize initiative and work independently
Ability to establish and maintain effective working relationships with coworkers, managers and clients

Regards,

Kavya 

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