Pharmacovigilance Services Specialist

 About The Role  

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance

Designation: Pharmacovigilance Services Specialist

Qualifications:Bachelor of Aryurvedic Medicine And Surgery/Bachelor Degree in Life Sciences/Master Degree in Life Sciences

Years of Experience:7 to 11 years

What would you do? Oversee and ensure adherence to Quality Management Framework procedures that is required in delivering high quality cases and managing the team??s performance

What are we looking for? Educational and Experience Requirements:?¢Bachelors in Life Science, Pharmacy, or a Medical Degree?¢4-5 years of experience in Pharmacovigilance?¢Specific experience of QA / auditing of any Pharma domains like Pharmacovigilance,?¢Clinical Operations, Medical writing, SAS, etc. is desired?¢Must have the ability to report facts with high degree of accuracy and attention on to detail.?¢General understanding of ICH, GCP, FDA, MHRA and similar requirements with respect to Clinical Trial and Quality Assurance experience will be desired. ?¢Good verbal and written communication skills desired.?¢Must have skills of Microsoft office tools like excel, word and power point etc.?¢Must be able to develop strong interpersonal skills within the team

Roles and Responsibilities: ?¢Implementation of Quality assurance program for PV Engagements.?¢Establish quality and compliance activities during transition of new deals.?¢Support in client, due diligence visits/audits and inspections by regulatory authorities?¢Support in SOP development and maintenance for the assigned project?¢Ensure data security / privacy measures are implemented in deal teams, by the delivery leads and deal representatives?¢Compliance oversight for the assigned project.?¢Attend governance meetings and provide quality updates?¢Support in deviation review and development of CAPA meeting the requirements.?¢Follow up on closure of CAPA?¢Closely monitor the contract updates and the changes required in the processes.?¢Focus on the standardisation of the process across the locations of an assigned project ?¢Ensure compliance with applicable regulations and deal guidelines including those that are brought to light subsequent to an audit?¢Serve as a resource for training and answering questions on applicable regulations and deal /client guidelines as applicable?¢Serve as point of contact for audits and audit follow-up?¢Inspection readiness?¢Develop Quality Management Plan for PV deal in compliance with the contract for?¢Accenture if required?¢Co-ordination of regulatory Audits in Various deals.?¢Additional responsibilities as and when required by the management
 Qualification Bachelor of Aryurvedic Medicine And Surgery,Bachelor Degree in Life Sciences,Master Degree in Life Sciences