Job Title: Pharmacovigilance Services Specialist
Location: Remote
Company: Accenture
About Accenture:
Accenture is a global leader in professional services, specializing in digital, cloud, and security. With over 699,000 people across more than 120 countries, Accenture delivers strategy, consulting, technology, and operations services to clients in over 40 industries. We embrace the power of change to create value and success for our clients, people, shareholders, partners, and communities.
Within Accenture, our Life Sciences R&D vertical spans clinical trials, pharmacovigilance, regulatory services, and patient services solutions, helping biopharma companies improve patient outcomes and advance healthcare innovation.
Role Overview:
As a Pharmacovigilance Services Specialist, you will play a pivotal role in pharmacovigilance operations and drug safety surveillance. You will be responsible for the management of safety reporting tasks, including Serious Adverse Event (SAE) and Non-serious case reporting, case identification, data entry, MedDRA coding, and ensuring compliance with global regulatory standards. This role involves ensuring the timely processing and submission of Individual Case Safety Reports (ICSRs) to clients, regulatory bodies, and investigators.
You will work as part of a dynamic team, contributing to global drug safety efforts, while leveraging your expertise to meet safety reporting objectives and regulatory requirements.
Key Responsibilities:
Case Management & Processing:
Manage and process ICSRs including Serious Adverse Events (SAEs) and Non-serious cases.
Handle case identification, MedDRA coding, data entry, and case processing according to client guidelines and regulatory requirements.
Perform follow-up tasks for adverse event cases, including written follow-up for both Serious and Non-serious cases.
Safety Reporting:
Ensure all safety reports are submitted on time to clients, regulatory authorities, ethics committees, and investigators.
Reconcile and manage the Affiliate Mailbox and other reporting channels.
Ensure proper documentation and submission of safety-related data as per guidelines.
Regulatory Compliance:
Ensure adherence to global regulatory standards and pharmacovigilance guidelines for case processing and submission.
Stay updated on safety reporting regulations and apply them to day-to-day operations.
Collaboration & Communication:
Work with team members, clients, and external stakeholders to ensure timely and accurate submission of safety information.
Communicate effectively with internal teams, clients, and management to ensure compliance and accuracy.
Analysis & Problem Solving:
Analyze moderately complex issues related to pharmacovigilance and develop solutions.
Adapt methods and procedures as necessary to meet regulatory requirements and client expectations.
Team Leadership & Guidance:
Potentially manage small teams or work efforts within the pharmacovigilance function.
Provide guidance and support to junior team members to ensure high-quality work and adherence to timelines.
Rotational Shift Work:
Be prepared to work in rotational shifts to ensure 24/7 safety reporting coverage across global clients.
What We’re Looking For:
Education & Experience:
Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) or MBBS (for Medical Reviewer).
7 to 11 years of experience in pharmacovigilance or drug safety.
Skills & Abilities:
Strong understanding of MedDRA coding, case processing, and pharmacovigilance regulations.
Ability to solve moderately complex problems and adapt existing methods.
Proficiency in data entry, case management, and safety reporting.
Excellent communication skills, both verbal and written, with the ability to collaborate across functions.
Additional Requirements:
Ability to manage small teams or lead individual projects.
Willingness to work in rotational shifts as needed.
What Accenture Offers:
Global Impact:
Work with leading biopharma companies to improve patient outcomes and drug safety worldwide.
Career Growth:
Opportunities for career development within a global company.
Access to Accenture's advanced technologies and expert networks.
Work Environment:
An inclusive, diverse, and flexible work culture that promotes work-life balance.
Comprehensive Benefits:
Competitive salary, health insurance, and retirement benefits tailored to your location.
Global Employee Assistance Programme to support you and your family’s well-being.
Accenture is committed to creating an inclusive environment for all candidates. We encourage applicants from diverse backgrounds and offer equal opportunities for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, disability, or protected veteran status.
If you're passionate about pharmacovigilance and want to contribute to advancing drug safety, we encourage you to apply and join Accenture’s dynamic and diverse team!
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