Pharmacovigilance Services Associate Manager

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance
Designation: Associate Manager
Qualifications:Any Graduation,Bachelor of Pharmacy,Master of Pharmacy
Years of Experience:10-14years
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What would you do? Overall responsible for PSUR team at ESP. Tracking of stages and milestones of aggregate reports as per predefined schedule. Follow escalation process as per Client process. Ensure training and mentoring of new aggregate reporting associates and documentation of the same. Address any quality related issues and implementation of quality improvement initiatives for the team. Provide delivery updates in monthly operation steering committee meeting. Ensure retention. Ensure project compliance according to Client SOPs. Timely generate RCA-CAPA for any SLA/ SOP deviation. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.
What are we looking for? Educational requirement: Medical Degree (MBBS) or Bachelors Degree in Pharmacy or Advanced Nursing Degree or Masters Degree in Life Sciences. Work experience requirement: Prior experience in managing service delivery (Experience in managing service delivery for pharmacovigilance or clinical data management functions preferred).
Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures The person requires understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor or team leads Generally interacts with peers and/or management levels at a client and/or within Accenture The person should require minimal guidance when determining methods and procedures on new assignments Decisions often impact the team in which they reside and occasionally impact other teams Individual would manage medium-small sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts