Job description General Manager, Pharmacovigilance (Clinical Trials & Medical Monitoring) Company: A fast-growing Contract Research Organization (CRO) into Pharmacovigilance, Medical Information, Medical Monitoring, Medical Writing and Regulatory Affairs Job Title: GM - Pharmacovigilance Department - Pharmacovigilance Role - To Lead Clinical Trials Client & Medical Monitoring team Job Location - New Delhi / Ahmedabad No. of Direct/Indirect reports - 8-10 team members Position report to - VP : Pharmacovigilance Experience: 10+ Years of experience and a minimum of 6 years of relevant experience. 1. DUTIES &amp; RESPONSIBILITIES Pharmacovigilance - Lead the team managing the offshore client operations for Clinical Trials and Medical Monitoring, covering the day-to-day operations like individual case processing, Periodic Adverse Drug Experience Reports (PADERs) preparation and review, and any other tasks relevant to the Pharmacovigilance Department - Quality Management of Information and Data Entry and QC &amp; Medical Review (if applicable) of the data entered in company's / client's hosted safety databases. - Quality Management and review of aggregate reports per the Regulations and SOPs - Management of Compliance with the Company Standard Operating Procedures and with regulatory requirements - Generation, Review and execution of Standard Operating Procedures - Signal detection of the ADRs with cases received from client's products (if required) - Liaise effectively and maintain excellent relationships with clients and external contacts. - Resourcing and hiring as per project requirements. - Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes - Monitoring the work progress, ensure timely delivery, participating in status meetings, updating project progress to the stakeholders - Assigning/reassigning tasks to reporting staff - To carry out the necessary administrative duties required for the job - To contact, as required, the UK/US office(s) and customers/ clients in order to achieve the required outcomes and meet timelines - Other duties as assigned by management - Continuously works with internal and external clients to ensure satisfaction - Trains and mentors new employees (if required) - Constantly works towards the identification of new training and development opportunities for the team members Medical Monitoring - Provide medical oversight regarding protocol exemptions, protocol violations, protocol eligibility issues, accepted medications, and general medical-related study issues - Review laboratory alerts, and coordinate appropriate follow-up with study site - Conduct training for the project team concerning the disease, drug, study design and procedures - Provide consultation to the study team during review of out-of-range laboratory values for clinical and /or protocol significance - Preview listings of AEs/SAEs, study withdrawal/Discontinuation, lab reports, and subject profiles as defined within the Safety Medical Monitoring Plan - Participation in DSMB meeting, review and provide the data and inputs for the same - Ensure all protocol inquires and answers are documented - Additional tasks may involve attendance and participation at Investigator Meetings, preparation of subject narratives, review of study reports and other documents, preparation and/or review of periodic and interim safety reports - Conduct a medical review of the Project Plan, Tables and Listings, and the Integrated Clinical Study Reports as appropriate - Monitoring the work progress, ensure timely delivery, participating in status meetings, updating project progress to the stakeholders - Liaise effectively and maintain an excellent relationship with the clients and external contacts. - Trains and mentors new employees (if required) 2. REQUISITE COMPETENCY AND QUALIFICATION Key Competencies: - Ability to establish effective working relationships with clients &amp; delivery heads - Ability to plan &amp; prioritize work effectively - Ability to effectively work independently, prioritize, multi-task and meet established deadlines Key Skills: - Knowledge of global regulatory requirements - Excellent Team handling and client handling skills - Good time management skills - Ability to prioritize and plan projects and work effectively - Good presentation skills - Strong interpersonal &amp; communication skills - Knowledge of Microsoft Office - Excellent analytics, critical-thinking and problem-solving skills Qualification: A graduate degree/post-graduate degree in Pharmaceutical Sciences/Life Sciences/Medical Science preferably MBBS/MD.

Delhi

Ahmedabad

Gujarat

General Manager - Pharmacovigilance - Clinical Trials & Medical Monitoring 

General Manager - Pharmacovigilance - Clinical Trials & Medical Monitoring  ,Job Description for General Manager - Pharmacovigilance - Clinical Trials & Medical Monitoring  in SetupMyHR in  Delhi Ahmedabad Gujarat for (8-20) years of experience. Apply Now!

Job Description for General Manager - Pharmacovigilance - Clinical Trials & Medical Monitoring  in SetupMyHR in  Delhi Ahmedabad Gujarat for (8-20) years of experience. Apply Now!