Pharmacovigilance Services Specialist

Pharmacovigilance Services Specialist

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Specialist
Qualifications:Bachelor of Pharmacy/Master of Pharmacy/Master Of Physiotherapy
Years of Experience:7 to 11 years
About Accenture
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What would you do? Oversee and ensure adherence to Pharma Quality Management Framework procedures for all CO sites that is required in delivering high quality cases and managing the team’s performance.
What are we looking for? - Graduate / post graduate - General understanding of ICH, GCP, FDA, MHRA and similar requirements with respect of Pharmacovigilance - High degree of accuracy and attention to detail - Good technical knowledge of medical terminology - Good verbal and written communication skills - Strong interpersonal skills within the team - Basic Excel, Word and PPT
Roles and Responsibilities: 1. Ensure compliance to the Pharma Quality Management framework procedures by: a. Reviewing the Quality Management Plan of the project and suggesting improvements. b. Collaborating with leads, Trainers and Quality Check / Quality reviewer in the engagement to implement new processes/enhance existing processes while ensuring compliance to quality standards. c. Ensure trainings, awareness sessions, refresher trainings/workshops are conducted for the team to understand case processing convention d. Ensure the engagement meets the SLAs pertaining to Quality every month. e. Ensure the Quality control process is in place by identifying gaps and learning opportunities. f. Collaborate with the Client Quality/Training teams in sharing best practices, identifying gaps and fostering knowledge transfer through e?ective communication. g. Ensure proper documentation of the RCA and CAPA for quality issues as outlaid in the processes. h. Drive zero quality issues leading to late submissions to the Health Agencies, Business Partners and License Partners. 2. Supporting SOP development and maintenance: a. SOPs related to Quality Management, Train the Trainer etc. b. Project Standard Work Instructions – Process documents. 3. Assure proper documentation storage and archival of the relevant records 4. Conduct awareness initiatives with respect to compliance within the project 5. Supporting in client due diligence visits, audits etc. 6. Supporting inspections by regulatory authorities 7. During transition phase, support the project by interfacing with several internal functions in order to establish: a. Job descriptions and skill sets are as per the contract b. SOPs/SWIs are agreed, in place and signed o? as per the contract c. JD’s and CV’s are available and maintained as per the contract d. Training approach and management of the training plans, documentation etc. are in place e. Enhancing audit management through learnings 8. Support in training: a. Ensure all employees are trained in Inspection Readiness process b. Ensure all employees are trained on the classroom sessions and trainings conducted through the client training space as per the de?ned training curriculum 9. Key performance indicators: Ability to learn quickly Consistent demonstration of company values/behaviours