Pharmacovigilance Services Assoc Manager

10-14 years

Not Disclosed

Bangalore

10 Nov. 21, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Associate Manager - Pharmacovigilance Services

Skill Required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance
Designation: Associate Manager
Qualifications: Any Graduation
Years of Experience: 10 - 14 years
Language Ability: English - Proficient

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 699,000 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?

Be overall responsible for managing the PSUR (Periodic Safety Update Report) team at ESP.
Track stages and milestones of aggregate reports according to the predefined schedule.
Follow escalation processes as per client guidelines.
Ensure training and mentoring of new aggregate reporting associates and maintain documentation of the training.
Address quality-related issues and implement quality improvement initiatives for the team.
Provide delivery updates during the monthly operation steering committee meetings.
Ensure retention and project compliance according to client SOPs (Standard Operating Procedures).
Timely generate RCA-CAPA (Root Cause Analysis and Corrective and Preventive Actions) for any SLA/SOP deviation.
Manage the Affiliate Mailbox, reconcile reports per process, and ensure written follow-ups for both serious and non-serious cases.
Handle case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs (Individual Case Safety Reports) in the safety database in compliance with client guidelines and global regulatory requirements.

What Are We Looking For?

Educational Requirement:

Medical Degree (MBBS)
Bachelor’s Degree in Pharmacy
Advanced Nursing Degree
Master’s Degree in Life Sciences

Work Experience Requirement:

Prior experience in managing service delivery, particularly in pharmacovigilance or clinical data management functions.

Roles and Responsibilities:

Analyze and solve moderately complex problems, leveraging and adapting existing methods and procedures.
Understand the strategic direction set by senior management and align team goals accordingly.
Interact primarily with direct supervisors or team leads, while also collaborating with peers and/or management levels at clients or within Accenture.
Require minimal guidance in determining methods and procedures for new assignments.
Make decisions that impact your team and occasionally other teams.
Manage medium-small sized teams and/or work efforts, either as an individual contributor or in a leadership role.
Note: This role may require you to work in rotational shifts.

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