Based on my experience I am giving you the ways to search
pharma jobs. After getting known this information, if you try genuinely, definitely
you will get the job. Along with the information am also providing the required
urls (uniform resource locator). So that
you can easily redirect to that pages or websites etc.
Methods to search pharma jobs can be divided as shown below.
A. Offline- by direct contact
First of all we will go through the offline ways, it does
not necessarily mean that you are not using help of internet, but it means the
major work done through offline.
In this method, you will approach your senior/relative/friend who are already working in the pharmaceutical industry. You provide them your resume, they will forward it to Human Resource (HR) department. You will get an interview opportunity, if you succeed, you will get the job. Story ends.
2. Resume distribution:
You have to take print outs of your resume. You have to go pharma industrial area (where you will find at least 10-20 pharmaceutical companies) and give your resume to front office/security office. If they have any urgent /bulk requirement with your qualification, you will get an interview call. If you are okay in interview you will get the job. Story ends.
Note: This is a tedious process. If you want to try this method, definitely you should go to any pharma/biotech industrial area on bike only. If you go on public transport, you can’t give more than 5/6 resumes in a day because pharmaceutical companies/plants are located far away from its next pharma company usually (200-400 meters distance from its next company). Some companies will not allow you to submit the resume. This is the worst experience we have ever faced.
3. Campus interviews:
If your college is good and have relationships with the employers, your first interview call will be offered from your college itself. But this percentage is very less.
4. Job fair:
These are usually conducted by Non profit organisations or colleges. Any body can attend this job or sometimes registration should be done. Care should be taken in job fair if you are going to pay money. There is no specific job fair conducted for only pharma people point of view. Pharma specific job fairs are rare. Job fairs usually conducted on colleges or grounds on specified dates.
Due to large number of students, they don’t have time to take interview. They will take resumes or contact numbers. Most of the times, non-technical jobs will be recruited by this way. If you need a technical job suitable for your qualification, you have to try other methods.
This a paid method. Other discussed methods in this website are
free to use and there is no involvement of third party person apart from you
and employer. Choosing a good consultancy is important in this method. Job
consultancies has it’s own advantages and disadvantages.
If you find a good trusted consultancy,
You need not to do anything to get an interview call.
You will have freedom to choose your interested department.
No need to strain more to get the reference.
You have to pay money
There is a chance of cheating (For ex. Consultancies should
have an official tie up with the employers. Some consultancies have an
individual tie-ups with HOD/HRs (this is not a correct way) to recruit the
employees. If everything goes good, no problem. Other wise recruited employees
will be treated as a back door employee).
Note: If you are preferring this method, try to pay major portion of the charged amount after receiving the first month salary only. If you get the salary on time like other employees, It is a sign of official confirmation from your employer.
Pharmacovigilance interview questions for freshers- Part 1
Pharmacovigilance interview questions given here in two parts. This post prepared from freshers point of view. Some of the questions may also be useful for experienced people. If you are looking for a job, you should aware of all these pharmacovigilance interview questions and answers. We have covered most of the questions usually asked in freshers interview for PV job . We hope that this pharmacovigilance interview questions will assist you face the interview successfully.
Explain about Pharmacovigilance?
Ans) It collects adverse effects information of medicines, biological products and the data is analysed, monitored to prevent the adverse effects or other drug or therapy related problems. AE information is collected form healthcare providers(Doctors/Pharmacist/Nurse etc.) and patients etc.
What is the difference between adverse drug reaction or adverse drug event
Ans) Adverse drug event (ADE) is an untoward medical occurrence when a medicine is administered to a patient. It is an unexpected and unpredictable reaction, which does not necessarily have a casual relationship with drug action. But Adverse drug reaction is a noxious and unintended effect. It has a relationship with the drug action. ADR is a harmful effect occurs at a normal dose and normal use.
Ans) Objectives the pharmacovigilance is to enhance the patient and public care and safety by reducing the occurrence of adverse effects and its severity.
To encourage the rational and safe use of drugs by increasing the awareness and understanding of drugs.
Explain about types of pharmacovigilance?
Ans) There are two types of Pharmacovigilance available i.e Active and Passive Pharmacovigilance.
Active PV: It involves active measures to detect the Adverse event occurrence after or during the treatment. Patients are directly asked or patient screening records are checked to find out the any experienced adverse events.
Passive PV: It wont involve any active measures to detect the adverse events/effects. This is also called as Spontaneous or voluntary reporting. This reporting is mainly depending on initiative and motivation of reporters like Healthcare providers (Doctors, Nurse, Pharmacist etc) and Patients.
Ans) Screening of several thousands/Lakhs of compounds, few compounds enter into the Preclinical Testing followed by Clinical Trials. Then NDA filed for getting marketing approval. Formulation will be in the market once the product got the regulatory authority approval.
Explain different phases in clinical trails ?
Ans) 3 phases involved in the Clinical Trials.
Phase I determines the drug safety and dosage by the help of pharmacokinetics of the drug. Except chronic disease (AIDS/Cancer) drugs, most of the remaining drugs tested in healthy volunteers.
Phase II: Once the drug safety confirmed, this phase starts to find out the effectiveness of the drug along with its side effects.
Phase III: This phase tested on a huge number (1000 to 3000) of patients. Before going to drug in the market, this phase confirm/ verifies the effectiveness of the drug in the trial.
Note: Phase 0 also belongs to the clinical trial phase known as micro dosing. Very small amount of the drug is administered in the human body to check whether the drug is behaving same as it is tested in the animals in the preclinical studies.
Japan- PMDA (Pharmaceuticals and Medical Devices Agency)
Brazil- ANVISA (National Health Surveillance Agency)
Australia – TGA (Therapeutic Goods Administration)
China – CFDA (China Food and Drug Administration)
Thailand – FDA (Food and Drug Administration)
Singapore – HSA (Health Science Authority)
Explain about Volume 9A?
Ans) European Union prepared this Volume 9A. It provides guidance on pharmacovigilance roles, requirements, procedures and activities. These guidelines are for both MAH (Marketing Authorisation Holders) and Human use medicinal product competent authorities.
It contains 4 parts.
Part 1 discuss guidelines for MAH (Marketing Authorisation Holders)
2nd part is about guidelines for Medicinal product competent authorise.
Part 3 is about guidelines for electronic exchange of PV in European Union and
4th part deals with the guidelines on PV communication.
What are the ICH guidelines related to Pharmacovigilance?
Ans) ICH E2A to E2F guidelines deals with pharmacovigilance.
E2A guidelines for Clinical Safety Data Management:
These guidelines deals with the terminology and standard definitions related to the clinical safety reporting. It also provides the guidelines on ADR rapid/expedited reporting mechanism during the investigational drug development phase.
E2B guidelines for Data elements transmission of ICSRs.
It provides guidelines on clinical safety data management and ICSR data elements transmission.
E2C –Periodic benefit risk evaluation report.
It provides guidelines on PSURs of marketed drugs which are having role in benefit risk evaluation.
E2D- It provides guidelines for Post approval safety data management.
E2E- It provides guidelines on Pharmacovigilance planning.
E2F- Development Safety Update Report: It provides guidance on DSUR. It is the data from the Investigational drugs in the clinical trials with or without having a market approval. Sponsors required to submit DSUR on every year.
Minimum data elements required for a valid case?
Ans) An identifiable reporter (Patient/Doctor/Pharmacist etc), An adverse event, An identifiable patient and an identifiable suspect product.
Expand ICSR, DSUR, PSUR, PADER, SUSAR MedDRA, GVP, IBD, ESTRI, WHO ART and CIOMS?
Ans) ICSR – Individual Case Safety Report
DSUR- Development Safety Update Report
PSUR- Periodic Safety Update Report: European Medicines Evaluation Agency (EMEA) needs this PSURs.
PADER-Periodic Adverse Drug Experience Report: USFDA needs this PADERs.
MedDRA- Medical Dictionary for Regulatory Affairs: MedDRA developed by ICH (International Conference on Harmonisation) and maintained by Maintenance Support Services Organisation (MSSO).
GVP- Good Pharmacovigilance Practices.
IBD- International Birth Date
ESTRI- Electronic Standards for the Transfer of Regulatory Information
WHO ART- World Health Organisation- Adverse Reaction Terminology: It is a dictionary for coding adverse reactions. WHO ART maintained by Uppsala Monitoring Centre (UMC), Sweden.
CIOMS-Council for International Organizations of Medical Sciences. For more information visit CIOMS website
When the MedDRA is updated?
Ans) In every year of March and September, MedDRA updated. March updates presented in Metathesaurus release of November and September updates presented in May Metathesaurus release.
What do you know about Thalidomide disaster?
Ans) Thalidomides used as a mild sleeping agent and to treat morning sickness in pregnant women in 1960s. The major side effect of this drug is Phocomelia (severe Birth defects affecting the upper and/ lower limbs and foetal death. Thousands of babies affected by the malformed limbs.
What do you know about Tuskegee Syphilis Experiment?
Ans) It was an unethical study. Researcher(Doctors from Public Health Services) included the Tuskgee (a city in Macon country, Alabama, United states) sharecrappers without giving the proper information about the study. It was started in 1932 to know the disease progression of syphilis( a sexually transmitted disease). This study was continued upto 40 years. Study involves 399 latent syphilis patients and 201 normal healthy people as control- they were being infected with variety of ailments of bad blood. Syphilis patients are left untreated for knowing disease progression even though penicillin recommended treatment is available for syphilis from the year of 1947. Nearly most study participants are injected with syphilis infection. At the end of the study, most of study participants were died with syphilis or with its related complications and their wife’s and children infected with syphilis.
Pharmacovigilance interview questions part 2 is continuation to this post.