Designation : Manager - Strategic Medical Affairs

Role : Medico Marketing

Functional Area : Medico Marketing, PV & RA - Pharmaceutical Formulations

Education : MBBS / MS, MD in Pharmacology

Industry Type : Pharma & Biotechnology

Experience : 2 - 5 Years

Compensation : Negotiable

Location : Ahmedabad

Job Description

Roles and Responsibilities

Medico Marketing:

• Detail data mining and literature review from different sources. Provide authoritative opinions and answer medically and scientifically based questions.
• Provide medical inputs into execution of brand strategy & new product development.
• Delivering Medical input series for marketing the products in form of PMS trials protocols, monographs, PI, crisp reference book with medical information for Visual aid and LBL, medical information for posters, slides for Patient Education and also validate the content of the copy and medical input generated from marketing end.
• New products identification & Business case preparation.
• Launch slides, training manuals and FAQ for launch & strategy briefing meetings.
• Medical insights, Medical Rationale for new molecules and existing molecules. People development by Conducting Medical training for marketing and field force. Impart product and disease area training to field force, when required, using approved training materials, to ensure that they have basic and up to date product and therapy area understanding.
• Create medical presentation for various national level conferences (based on our PMS trials and other recent material on our products), RTMs, CMEs and actively participating in the same by being speaker or moderator of the session.
• Coordinate for PMS trials.
• Liaisoning with top KOLs who can be our members for Advisory board to seek inputs w.r.t company's current and future products and for planning CME programmers.

Regulatory:

• To ensure every product's leaflet/product information (PI) contains valid scientific information and meet with international standards.
• To approve artworks include the works on Blister/Cartons as mentioned in SOP guidelines.
• To keep record of all final approved labels, cartons and leaflets with signature/approval of responsible authority.
• Provide medical expertise in creation and maintenance of the labels for Company's products.
• Review of safety information document like country level labels, pack inserts and patient information leaflets.
• Monitoring of safety labelling of products of other companies as and when required and assist in implementation of health authority requested for safety - related labelling changes.

Pharmacovigilance:

• Assist in implementation and maintenance of Standard Operating Procedures (SOPs), where applicable to ensure that there are clear written procedures in place describing the Pharmacovigilance system.
• Ensure case's medical / causality assessment performed by PV Service provider is valid.
• Ensure literature search performed by the PV Service providers meet the agreed SLAs.
• Keep record of monthly activity and invoice received from PV Service providers.
• Provide all safety related information related to products to concerned stakeholder/ PV Service providers.
• Assist in preparation of clinical & non - clinical overviews/ summaries for dossiers as and when required.
• Resolve the queries received from PV Service providers on ICSRs assessments, safety data / cases validation, PSURs, PADERs, REMS and signal detection report prepared by concerned stakeholders.
• Assistance in keeping oversight of all PV inspections/audits/CAP As and local remediation plans in collaboration with concerned stakeholders as required.
• Assist in perform review of PSURs, PADERs, REMS and signal detection report prepared by concerned stakeholders.
• Assist in maintaining awareness of local and global PV regulatory requirements with concerned stakeholders having responsibility of PV activities.

Roles and Responsibilities

• Clear understanding of local medical practice and clinical decision making in regards to patient care. Understanding of healthcare systems supporting patient care.
• Thorough knowledge of medicine (including pharmacotherapy), treatment guidelines, clinical research processes, customer strategies, regulations, and various guidelines applied to the pharmaceutical industry.
• Interpretation of key scientific data and ability to translate these information to meet educational and research needs. In-depth knowledge of targeted therapeutic area may be an additional advantage.