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 Bachelor’s Degree in Pharmacy or Advanced Nursing Degree or Master’s 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