Product specialist
Sana Pharma
Total des années d'expérience :8 years, 4 Mois
Making promotional material for finished pharmaceutical products ( Brochure, Flyer and
Poster)
Preparing information for packaging material of finished pharmaceutical products ( leaflet,
label and box)
Preparing clinical summaries for products based on clinical evidence
Making recommendations for new pipeline products including both herbal and medicinal
with evaluation for both safety and efficacy
Good experience in analyzing products competitors and making manufactured products differ with greater efficacy and safety
Helping the patients by answering any questions they need about the products (Direction
of use, Side effects, etc.)
Preparing eCTD files
Gathering data and preparation of technical dossiers
Do necessary paperwork and documentation processes
Monitoring drug safety and efficacy to ensure that drugs which are marketed by MAH are
safe and effective
Preparing SOPs, PSMF, ICSR, notification sheet, PSUR, and RMP as a part of
Pharmacovigilance activities
Analyzing risk-benefit ratio of the marketed product and do risk minimization activities to
maximize the drug benefit
Communicating HCPs through medical representatives to ensure proper use of medicinal
product in order to minimize the risk associated with its improper use
Building a system for ensuring collection of Suspect adverse drug reaction reports and
doing causality assessment of these reports to be submitted for JFDA in a timely manner
Doing corrective and preventive actions in coordination with JFDA in case of occurring of
new safety or efficacy concerns regarding the marketed medicinal product
Giving ideas for developing new drugs and medicated cosmetics with added benefits
Preparing proposal for a new value added medicines and proceed in their approval by
JFDA
Evaluating both safety and efficacy profiles of drugs before proceeding in their
manufacturing
Choosing JFDA licensed CRO in cooperation with general manager
Choosing qualified principle investigator and licensed clinical sites for conducting a trial after doing site evaluation visit
Conducting regular visits for clinical site to ensure compliance with SOPs, local regulation, protocol, and ICH-GCP guidelines and writing visit report
Communicating with CRO to discuss the clinical trials required by JFDA for the value added drug
Reviewing the study protocols prepared by CROs before proceeding in their approval by a sponsor
clinical pharmacist with Grade of 3.54 of 4