Pharmacovigilance Services Specialist-Pharmacovigilance

7-11 years

Not Disclosed

Chennai

10 May 24, 2024

Job Description

Job Type: Full Time Education: MBBS Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Medical Review Scientist
Skill Required: Pharmacovigilance - Medical Review
Job Location: Chennai
Qualifications: MBBS
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 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? You will be aligned with our Life Sciences R&D vertical. Our services span the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services to pharmacovigilance and patient services solutions. Employees in this span will be part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies improve outcomes by converging around the patient and connecting scientific expertise with unique insights into the patient experience.

Key Responsibilities:

Detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem following Good Pharmacovigilance Practice (GVP) per client SOPs and applicable global regulatory requirements (Individual Case Safety Reports).
Work on various aspects of Aggregate reports such as planning, authoring, reviewing, and publishing of PBRER, PSUR, DSUR, PADER, Addendum to clinical overview (AdCO), Risk Management Plan (RMP), Signal detection and validation reports (SDVR), Cosmetovigilance Safety Reports (CoSR).
Author and review clinical documents such as Protocols and amendments, Investigator Brochure, Clinical Study Reports (CSR), Synoptic/Abbreviated CSR, Safety Narratives, Clinical Overview/abbreviated Clinical Overview.
Collect and perform a clinical review of medical records and related information to ensure that payment is made only for services that meet all Medicare coverage, coding, billing, and medical necessity requirements.
Review and assess seriousness, causality, and labeling/expectedness of adverse events of individual case safety reports in compliance with client SOPs and global regulatory requirements.

What are we looking for?

Ability to establish strong client relationships
Adaptable and flexible
Detail orientation
Problem-solving skills

Roles and Responsibilities:

Analyze and solve moderately complex problems
Create new solutions, leveraging and adapting existing methods and procedures as needed
Understand the strategic direction set by senior management as it relates to team goals
Primary upward interaction is with the direct supervisor
May interact with peers and/or management levels at a client and/or within Accenture
Guidance provided when determining methods and procedures on new assignments
Decisions often impact the team
Manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
Note: This role may require you to work in rotational shifts.

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