Product Launch
- Conduct comprehensive literature search, prepare Medical manuals and Powerpoint slides.
- New Product Launch Presentation to the Marketing team and to the field with technical inputs on therapy area and product details.
Responding to Queries
- Ensure good customer relations by addressing queries from field force and doctors along with relevant scientific support.
Scientific Support to the Brands
- Keep abreast of the latest scientific information on products, therapy areas, landmark trials, guidelines from scientific associations on therapy areas.
- Provide technical support to the Marketing/Sales Department in terms of references on new as well as existing products.
- Prepare prescribing Information.
- Validate medical content in marketing inputs for accuracy and high scientific quality.
- Organize CME Kits including Powerpoint slide presentation and important references.
Training
- Dissemination of medical information by conducting training programs for fresher and refresher course for medical representatives.
New Product Ideation
- Provide medical rationale (Justification) for new product introductions.
- Evaluate and suggest novel products, indication expansion, unique dosage form, etc.
Publications
- Prepare manuscript for publication in peer-reviewed journals on original research and review article.
Other Responsibilities (accounting to 10%)
Clinical Trials
- Prepare and review the Protocol & CRF for conducting Phase III/IV trials, PMS and PSUR.
Regulatory Affairs
- Licensing of new products for domestic market (DCGI/FSSAI) - Involves coordination with R&D, QA department, CROs for submission of dossiers for product registration.
- Provide technical backup to CROs/R&D/QA department for preparation of regulatory documents for domestic and international market.
Pharmacovigilance
- Provide high quality medical writing from planning and coordination of literature research.
- Draft and review PSURs/PBRER with focus on medical aspects of the products and safety sections.
- Review of RMP as per Indian and International regulatory requirement.
- Good knowledge in assessing the risk-benefit of a product and identify any gaps in the aggregate documents.
- Perform scientific review of aggregate reports/ICSRs produced by PV Associates.
Compliance of Packaging Modules
- Prepare package insert as per New Drugs and Clinical Trials Rules 2019.
- Formulate and implement statutory requirements pertaining to the artworks of theproducts (label, carton, package insert, patient information leaflet, etc.).
- Review the artwork of all packaging materials.