Officer - Medical Services Glenmark Pharmaceuticals Ltd

Summary: To collect, monitor, assess and evaluate information received through Perception, Opinion & Expertise of Medical Professional studies in order to research a target market and get a feedback of our Products.
This would help to ensure that enough safety information is available on the products that we market across the globe.

PERCEPTION, OPINION & EXPERTISE OF MEDICAL PROFESSIONAL (POEM) STUDIES:

List of doctors with contact details / consent letters are received from marketing team.
Keeping track of booklet received.
Maintenance of study documents and replication of data into excel sheet.
Maintaining and updating internal database for POEM studies
Updating the marketing team on regular basis for receipt of POEM study documents
Analysis of the data after data entry is done.
Preparation of Final report
IN CLINIC DATA COLLECTION (ICDC) STUDIES:
List of doctors with contact details/ consent letters are received from marketing team
Handing over ICDC booklets over to respective doctors
Undertaking Follow ups at regular intervals to collect necessary information with respect to patient
recruitment status, adverse events and to check the progress of the study.
Collection and maintenance of Study documents after completion of the study
On receiving the completed ICDC booklets, the data is transcribed into excel sheet to prepare a database for further analysis.
Booklets with adverse events are reported to PV department
Keeping track of booklet received.
Compliance of local ICDC SOPs.
PHARMACOVIGILANCE:
Timely reporting of any adverse events to Pharmacovigilance System
Receive and track all spontaneous and clinical study cases
Forward reports to Central Processing or to Contractual partner as appropriate.
Follow up of certain cases
Source records retention
Coordinating with MIDAS (Medical Information Service) Manager for any safety information
Training of field force and maintain records of training.
Adhering to LPvRP working guidelines
Perform QC check of reported cases to contractual parties fortnightly.
Coordinating with marketing/CQA in case of Product complaints or adverse events
Coordinating with Global PV team to provide them with required information/documents

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Opening for Medical Writing/ Scientific Writing at Indegene, Bangalore

Kindly find the job description:
1.Responsible for authoring regulatory/ safety documents such as Protocol, CSR, IB, Clinical Overviews & Summaries, Subject Narratives, Aggregate Reports, RMPs and others
2.Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations
3.Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards. Update SOPs and other job aids for completeness as needed



Required Skills:
1. Minimum 4 years of experience in pharmaceutical companies in any of the following functionsregulatory-medical writing/developing/publishing medical content
2. Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field.
3. Strong flair and passion for writing.
4. Strong written and verbal communication/presentation skills.
5. Passion for networking.
6. Being up-to-date with the latest technical/scientific developments and relating them to various projects.

M. Pharm/BDS/ MBBS/ Ph.D with 3 to 4 years of experience in Regulatory Writing

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