Unichem Laboratories Hiring Manager – Medical Affairs and Pharmacovigilance

RESPONSIBILITIES

• Launching of new products – Providing scientific support for new products along with training the sales field for the respective products.
• Provide scientific updates for marketing authorization
• Handle product related queries from KOLs
• Prepare scientific material for various scientific sessions
• Conduct training of Pharmacovigilance at corporate office, manufacturing plants and to vendors if applicable
• Assist Pharmacovigilance team in medical affairs as well as drug related queries
• Support the Pharmacovigilance team to review SOP documents such as PSURs, RMPs
• Update the scientific information of the product (training slides, CME slides, literatures and maintained the database)
• Respond to medical queries from internal as well as external stake holders with scientific information on product
• Assist in developing protocol synopsis, approval of final synopsis, providing supporting documents (Investigator brochure, draft prescribing information, clinical and non-clinical data)
• Assist in providing medical and product expertise towards registration of new products with the regulatory authorities by providing the medical rationale and published literature on the products
• Review and approve promotional material like LBL and VA
• Collaborating with the brand management team for preparation and execution of strategic and operational plans for currently approved brands
• Development and execution of medical affairs plans for approved and pipeline compounds with the medical affairs Head.
• Provide continuous technical and medical support to marketing and sales teams regarding products
• Assist regulatory affairs teams regarding current norms for approvals if needed i.e. updated information on PI, SmPC
• Write a review article, case study and post marketing study
• Organize CME and other promotional activities if needed

Apply HERE