Medical Affairs

Job Description

Greetings !We are in Search of Dynamic, Enthusiastic, individual to carry out Medical Affairs Activities, as detailed below :Company Profile : The multi divisional organization having diversified interests in Ethical Formulations, Bulk Drug, Ayurvedic Medicine, Healthcare, Herbal Products and Bio-technology, seeds and Tissue Culture.Position : Manager - Medical Affairs.Location : Vile Parle-MumbaiQualification : MPharmExperience : 2-6 years of working exposure to Medical AffairsJob Description: Candidate will be responsible for :Medico- Marketing / AffairsPreparation for Product Launch inputs & medical write ups,Providing scientific solutions to the queries from Filed Force or Practicing PhysicianPreparation of Slide decks in line with SOP for various topicsAnswering queries from field force in timely manner with regulatory compliancePreparing on Training Modules for field force and impart training if requiredProviding strategic inputs and support towards creation of marketing/brand plans for the existing as well as new product launchesHandling product related scientific queries from Doctors / PMTsPreparation of promotional and training material in compliance.Scientific support for various activities like CME / RTMPreparing Monograph, Medical write ups, and literature of the products for the marketing teamSharing the latest updates regarding the therapy within the Medical teamPreparation of the newsletters and sharing the latest trends in the therapy, Diagnosis and treatment updates with the team.Coordinating and conducting the monthly training sessions for the field people.Managing the project of the clinical trial study.Thorough knowledge of Literature search and extraction of required articles full textPSUR and other regulatory Document submission whenever requiredKeeping a thorough vigil with Vendor and effectively coordinating with Safety reports and may require to conduct audit the Vendor at regular intervals.Involved in clinical-trial activities: reviews the pharmacovigilance aspects of protocols and other documents; ensures management of adverse-event case reports; reconciles information in pharmacovigilance and clinical research databases.Contributes to ensure Regulatory compliance of pharmacovigilance activitiesCausality Assessment, labelledness of ICSR, Literature monitoring, CIOMS, Good pharmacovigilance practices (GVP) Module VI effectively.Regulatory and Clinical TrialPreparation and review of Pack insert of various products according to SOP which comply with national and international guidelines.Thorough knowledge of ICH-GCP guidelines, Preparation of CT protocols,IBs, Site feasibility, monitoring and termination visits to various CT centers according to SOP and checklists.Travel to and monitor clinical trial sites to make sure that ICH GCP guidelines, study protocol and applicable regulations are being followedPreparing site visit reports and constant touch with PIsEnsure that only qualified individuals are working as site staff and that they are adequately trainedEnsure data collected is accurate and verifiableEnsure that the site has acceptable infrastructure and that it continues to remain so throughout the studyAct as a mentor to site staff and provide continuous support and guidancePreparation of Rationale and Justification based on Company requirements.Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirementsKey Skills and CompetencyCommunication and Interpersonal Skills Ability to build relationships of trust and demonstrate professional ethics.Problem Solving Ability to assess various situations and develop appropriate solutions.Very good knowledge of MS officeDecision-Making Ability to make sound judgments and properly assess situations.Multi-tasking and prioritizing the work based on needsAbility to keep tight deadlines and work under pressure.Adhere to all HR policies and procedures, to include all absence policies and proceduresIf Job Profile Suits You And Interested In The Opening, Please Mail Your Updated CV on hidden_email indicating following details,
• No. of years experience in Medical Affairs / Medico Marketing
• Exposure to Dermatology/Cosmatology
• Present Salary (CTC)
• Expected Salary (CTC)
• Notice Period
RegardsAshaYou may speak to P R Sawant on hidden_mobile

Keyskills :
medico marketingregulatory compliancemedical affairstraining modulesscientific traingingscientific promotion