Managing Partner at SetupMyHR
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General Manager - Pharmacovigilance - Clinical Trials & Medical Monitoring (8-20 yrs)
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 & 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 & 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 & delivery heads
- Ability to plan & 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 & 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.
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