Job title: Senior Manager – Medical Affairs & Regulatory Affairs – Pharma
Company: Avtar The Power of Diversity
Job description: Sr.Manager – Medical Affairs and Regulatory affairs
Key Responsibilities:
– Preparation, review, and amendments of clinical trial related documents like protocols, ICFs, data collection tools (except CRF), and clinical trial reports as per departmental SOPs.
– Medical Monitoring for all phases of clinical trials- Provide expert assistance in all phases of a trial e.g., during recruiting, data collection etc.
– Medical monitoring related training
– Monitoring of the appropriateness of the patient population enrolled in the trial by ongoing review of eligibility and support to investigator during the enrollment
– Review of AE/Adverse drug Reactions (ADRs), SAEs and reported pregnancies (if any)
– Review of Laboratory Parameters
– Review of Concomitant Medications
– Evaluation of Protocol Deviations
– Handling of Protocol queries (Medical)
– Handling of Ethics committee queries (Medical)
– Review and follow-up of pregnancies occurring in clinical trial subjects
– Review of serious Adverse Event (SAE) reports and ensure reporting of SAEs according to applicable regulations and sponsor requirements for all clinical trials wherein he/she works as Medical Monitor/Back-up Medical Monitor.
– Review of MedDRA, and WHO-DDE coding
– Carry out analysis and Clinical Study Report(CSR) writing in co-ordination with Head-CD and Sponsor.
– Development of departmental SOPs and training of CD personnel and stake holders on the same
– Impart training to the CD personnel/stake holders on SOPs, guidelines, functions of the CD, special topics, and therapeutic area training after being designated by head-CD.
– Training clinical research staff, investigators and relevant personnel on clinical trial requirements in investigator meetings and site initiation visits
– Training clinical research staff on therapeutic areas as and when necessary
– Assist the Head-CD in coordinating with the Legal department for finalizing all relevant agreements and contracts necessary during the conduct of in-house clinical trials
– Prepare and coordinate for CQA Audits
– Review of SVQs (Site Validation Questionnaires) for feasibility of studies
– Perform other responsibilities related to the Medical Affairs department and responsibility assigned by Department Head
Expected salary:
Location: Bangalore, Karnataka
Job date: Wed, 09 Nov 2022 03:34:06 GMT
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