Medical Affairs

Job Description

Greetings !We are in Search of Qualified MBBS Doctor for carrying out Medical Affairs activities , as detailed below :Company Profile : The multidivisional organization having diversified interests in Ethical Formulations, Bulk Drug, Ayurvedic Medicine, Healthcare, Herbal Products and Bio-technology, seeds andTissue Culture.Position : Officer Medical Affairs. Qualification : MBBSLocation : Vile Parle-MumbaiExperience : 1-2 years of working experience or FresherJob Description : Candidate will be responsible for :Pharmacovigilance
• The Pharmacovigilance officer looks after the companys Pharmacovigilance activities which includes maintaining the database of all ADR, analyzing ICSR, reporting it to Regulatory authority and maintaining the timelines of all serious and non - serious cases which comply with regulatory authorities.
• PSUR and other regulatory Document submission whenever required
• Keeping 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.
• Monthly maintaining and submission of reconciliation reports to Third party
• Contributes to ensure Regulatory compliance of pharmacovigilance activities
• Reviews data against source documents and knowledge of MedRA coding and PV guidance document
• Causality Assessment, labelledness of ICSR, Literature monitoring, CIOMS, Good pharmacovigilance practices (GVP) Module VIeffectively
Regulatory and Clinical Trial
• Preparation and review of Pack insert of various products according to SOP which comply with national and international guidelines.
• Travel to and monitor clinical trial sites to make sure that ICH GCP guidelines, study protocol and applicable regulations are being followed
• Preparing site visit reports and constant touch with PIs
• Ensure that only qualified individuals are working as site staff and that they are adequately trained
• Ensure data collected is accurate and verifiable
• Ensure that the site has acceptable infrastructure and that it continues to remain so throughout the study
• Act as a mentor to site staff and provide continuous support and guidance
• Preparation of Rationale and Justification based on Company requirements.
• Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements
Medico- Marketing(under supervision)
• Thorough knowledge of Literature search and extraction of required articles full text
• Preparation of Slide decks in line with SOP for various topics
• Answering queries from field force in timely manner with regulatory compliance
• Training of field force (if required)
Key Skills and Competency
• Communication 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 office
• Decision-Making Ability to make sound judgments and properly assess situations.
• Multi-tasking and prioritizing the work based on needs
• Ability to keep tight deadlines and work under pressure.
• Adhere to all HR policies and procedures, to include all absence policies and procedures
Candidates having required Qualification & Experience, please share your updated CV onhidden_email indicating
• Present Salary
• Expected Salary
• Notice Period
RegardsAshaYou may speak with P R Sawant on hidden_mobile.Please send this mail to your colleague, friend, having required exposure & looking out for change.

Keyskills :
clinical trialsmonitoringsearchpharmacovigilanceliteratureregulatory complianceaffairsmedical