Jr. Medical Advisor/Executive Medical Affairs Job Description -Be current with the regulations and requirements in Europe and India
-To respond to medical and technical queries from Health Care Professionals and internal customers by accessing appropriate high quality data from websites, literature and publications in a timely, efficient and ethical manner.
- Focused database/literature searching to support business associates with quality scientific information to address competition in the market. To ensure that the data is fully explained to our internal customers for them to use it in the best possible way.
-To assist the Medical Affairs Department to sign off promotional material, by critically assessing the claims made and the supporting data quoted. Should, when necessary, do data search to support the rationality or irrationality of claims and bring the data to the notice of Medical Advisor and Sr, Golbal Medical Affairs Advisor.
-Participate in the preparation of drafts for Standard Operating Procedures (SOP) for selected activities to ensure that consistency, allocation of responsibilities, accuracy and timeliness among other things is ensured. Once SOP is finalized, assist the Medical Affairs Department to meticulously implemented the same.
-Plan, organize, supervise and get the scientific and ethical bioavailability/bioequivalence studies completed on time (under the guidance of Head Medical Affairs) to support the product registrations in the countries of interest.
-Support the pharmacovigilance partner/teams to ensure that company continues to get the quality service from the vendor
-Evaluate potential new products for marketing that could be of interest to the Company in various international markets.
-As a member of Medical Affairs team, work closely with the Regulatory Affairs to support their needs for documentations to register the products.
-Answer queries from the Health Authorities related to products marketed by the Company in a scientific manner and supporting the necessary submissions with an appropriate data.
-Actively support the pharmacovigilance activities and risk management plans, recommended and/or finalized by the Company or its pharmacovigilance partner.
-Revise and/or supervise revision and approve the scientific documents for the products marketed by the Company, such as summary product characteristics (SPC), patient information leaflet/literature (PIL) etc. in compliance with
-The guidance from the Clinical Expert Statement (CES) from Periodic Safety Update Reports (PSUR) received from pharmacovigilance partner and
-Approvals from Regulatory Agencies, as information received from the Regulatory Dept.
-Harmonize SPC/PIL for different countries (e.g. UK/Ireland), as per the regulatory requirements/variation.
-Update PIL for user testing under the guidance of Head Medical Affairs and offer necessary assistance to the business units during user testing.
-To undertake the domestic and international travel under the guidance of superior to support the Company’s business needs and activities, when necessary.
-Assist the Medical Affairs team members in carrying out and documenting the training of the company staff in pharmacovigilance and medical details related to the products marketed by the Company.
-Prepare and update abbreviated prescribing information, whenever necessary and appropriate.
-Carry out the data/literature search and prepare a scientific documentation to support the rationality of the products marketed or proposed for marketing by the Company.
-Prepare detailed and accurate reports on activities planned or carried out on regular basis and submit them to the Head of Medical Affairs.
Desired Profile 2 years of experience in the medical affairs/medicomarketing in the pharmaceutical industry
Experience 0 - 2 Years
Industry Type Pharma/ Biotech/Clinical Research
Functional Area Healthcare, Medical, R&D
Location Mumbai
Keywords medicomarketing, medical advisor, medical advisory, medico marketing
If you meet the above mentioned criteria, apply online
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