Internship in Pharmacovigilance

This will help candidates understand the kind of work being done in the field of pharmacovigilance from the industries point of view

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HIGHLIGHTS OF THE PROGRAM

Month 1

Module 01: Introduction to pharmacovigilance
Module 02: Pharmacovigilance regulations and regulatory authorities
Module 03: ICH Guidelines, GVP Modules for pharmacovigilance
Module 04: Adverse Event Reporting forms (CIOMS, Yellow card, MedWatch)
Module 05: Drug safety evaluation in special population

Month 2

Module 06: Entries related to pharmacovigilance reporting databases (ARGUS)
Module 07: Adverse events (AEs) and Adverse drug reactions (ADRs)
Module 08: Causality or causal relationship determination

Module 09: Dechallenge and Rechallenge

Module 10: Drug exposure during pregnancy and breastfeeding

Month 3

Module 11: Narrative formats for various case reports

Module 12: Spontaneous, Literature and Study reports

Module 13: Valid and invalid reports

Module 14: Assignment and case studies
Module 15: Miscellaneous (Other topics)

CANDIDATE WILL BE RESPONSIBLE FOR

Manages and understand adverse events.
Spread awareness about pharmacovigilance.
Update and assessment of adverse events and reports
Writing to Heathcare professionals on signals.
Case processing in Pharmacovigilance
MedDRA Coding
Narrative Writing
Preparation of Reference safety information documents.
Conducting seminar about Pharmacovigilance.
Processes adverse-event case reports and conducts follow-up.
Notifies regulatory agencies and business partners accordingly.
Triage the reports.
Review of completed work
Responds to requests from regulatory agencies.
Reviews scientific literature and bibliographic sources.
Helps draft and manage RMP and periodic safety-update reports.
Evaluates safety profiles.
Ensures document filing and archiving.
Involved in clinical trial activities.
Reviews the pharmacovigilance aspects of protocols and other documents.
Ensures management of adverse-event case reports.
Reconciles information in pharmacovigilance and clinical research databases.
Contributes to ensure compliance of pharmacovigilance activities assures compliance of pharmacovigilance activities.
Conducts case reconciliation with concerned departments or business partners.
Takes part in audits and inspections.
Serves in an advisory capacity: revises product monographs.
Drafts responses to pharmacovigilance requests from regulatory agencies.
Advises and informs health professionals about product safety; participates in the drafting and implementation of pharmacovigilance contracts and agreements.

STUDENTS REVIEWS

"I love to hear all the information and gain so much knowledge about PV. I would also like to take part in next year for sure. Taking this course, I am more knowledgeable about side effects and more development so that I am also be a part of this health wand wealth program. Thanks, dear Mentor for such a wonderful session"

Tushar Ranjan Dash

CONGRATULATIONS TO ALL SELECTED CANDIDATES-1.jpg

Student Internship program in Pharmacovigilance for three months.

This is an amazing opportunity to learn skills and get trained in Pharmacovigilance and Medical Writing from Global Pharmacovigilance School, Mohali which requires following personnel purely on internship basis for three months with following terms and conditions:

Duration: Three months from date of commencement of training.

Essential Qualification: Students pursuing final year or completed Graduate degree (B.Pharm, BDS, Pharm.D) and postgraduate in life sciences (M.Pharm, Ph.D, MSc biotechnology, Biochemistry, Microbiology, Biophysics, MBBS, MD, MDS or related fields). (MSc chemistry need not apply).

Stipend: Not applicable.

Application fee: Rs 1,500 (To be paid ONLY if you are selected).

Application Procedure

All interested candidates may need to share the duly filled application form available along with PDF copies of degree certificates and transcripts via email at internship.globalpvschool@gmail.com
Incomplete application form and applications that are not in proper format and attachments may be rejected.
Candidates should ensure that information mentioned in application form is accurate. Once the application form is submitted no further request regarding any changes/ information in the application form will be considered.
The candidates must ascertain their eligibility before applying, as ineligible candidates will not be interviewed virtually.
All the candidates are requested to appear for a virtual interview (online on Microsoft teams application mode, details to be communicated later) with a personal, professional introduction, summary of experience, achievements, publications (if any) etc.
Interview will be conducted online and therefore No TA/DA will be paid for appearing in the interview.
Canvassing in any form or bringing influence, political or otherwise, will lead to disqualification of the candidate(s).
Candidates should strictly adhere with guidelines issued by Organization.
Upon the completion of home based/online 3 Months internship program in pharmacovigilance, completion and or appreciation certificates shall only be issued to the intern only if the project closure report (Survey, PowerPoint presentation, assignment etc. based on qualification) is submitted and reviewed by the organization.

Program Coordinator

Global Pharmacovigilance School

Mohali-140301, Punjab, India

E-mail: globalpharmacovigilanceschool@gmail.com

Website: www.globalpvschool.com

Phone: +91-7681914757, +91-7973247200

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