Pharmacovigilance Services Specialist

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
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Songall powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
What would you do Oversee and ensure adherence to Quality Management Framework procedures that is required in delivering high quality cases and managing the teams performance

What are we looking for EducationalBachelors in Life Science, Pharmacy, or a Medical Degree4-5 years of experience in PharmacovigilanceExperience RequirementsSpecific experience of QA / auditing of any Pharma domains like Pharmacovigilance,Clinical Operations, Medical writing, SAS, etc. is desiredMust 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 authoritiesSupport in SOP development and maintenance for the assigned projectEnsure data security / privacy measures are implemented in deal teams, by the delivery leads and deal representativesCompliance oversight for the assigned project.Attend governance meetings and provide quality updatesSupport in deviation review and development of CAPA meeting the requirements.Follow up on closure of CAPAClosely 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 auditServe as a resource for training and answering questions on applicable regulations and deal /client guidelines as applicableServe as point of contact for audits and audit follow-upInspection readinessDevelop Quality Management Plan for PV deal in compliance with the contract forAccenture if requiredCo-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