Pharmacovigilance Specialist

Pharmacovigilance Services Associate Manager

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Associate Manager
Qualifications:Any Graduation,Master of Pharmacy
Years of Experience:11- 15 Yrs
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 Song— all powered by the world’s 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? Responsible for leading the Signal Management activities including weekly literature review, authoring of signal reports (Signal Management and Review Team [SMART] reports) and project management of Safety Surveillance team (SST) meeting within the, agreed time frames and accuracy, in compliance,butsiness metrics, standard operating procedures (SOP) and global regulatory requirements, as applicable.Pharmacovigilance Services involve the detection, assessment, and prevention of adverse effects related to pharmaceutical products. These services ensure the safety and efficacy of medications by monitoring and analyzing data from clinical trials, healthcare providers, and patients. The goal is to identify potential risks and take appropriate actions to protect patient health. They also help pharmaceutical companies comply with regulatory requirements. Effective pharmacovigilance services are essential for maintaining public trust in medications.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? •Problem-solving skills•Detail orientation•Written and verbal communication•Risk management•Collaboration and interpersonal skills
Roles and Responsibilities: •In this role you are required to do analysis and solving of moderately complex problems• May create new solutions, leveraging and, where needed, adapting existing methods and procedures• The person would require understanding of the strategic direction set by senior management as it relates to team goals• Primary upward interaction is with direct supervisor• May interact with peers and/or management levels at a client and/or within Accenture• Guidance would be provided when determining methods and procedures on new assignments• Decisions made by you will often impact the team in which they reside• Individual would manage small 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