Job Title: Pharmacovigilance Services Specialist
Location: Remote
Company: Accenture
About Accenture:
Accenture is a global professional services company with leading capabilities in digital, cloud, and security. With over 699,000 people across more than 120 countries, we provide services in Strategy & Consulting, Technology & Operations, and Accenture Song. We work with clients from more than 40 industries and leverage cutting-edge technology and human ingenuity to create value and success. In our Life Sciences R&D vertical, we support biopharma companies in improving patient outcomes through research, clinical trials, pharmacovigilance, and regulatory services.
Role Overview:
As a Pharmacovigilance Services Specialist, you will play a key role in case management and drug safety surveillance. You will work with global biopharma companies, helping them ensure the safety of their products through adverse event reporting, data entry, case processing, and regulatory submissions. Your role will require in-depth knowledge of global pharmacovigilance regulations and processes, and you will work closely with clients, peers, and supervisors to ensure compliance and high-quality service delivery.
Key Responsibilities:
Case Management & Processing:
Identify and process Individual Case Safety Reports (ICSRs), including Serious Adverse Events (SAEs) and Non-serious cases.
Perform MedDRA coding, data entry, and case processing in accordance with client guidelines and global regulatory requirements.
Perform follow-up tasks for both Serious and Non-serious cases to ensure accuracy and compliance.
Safety Reporting:
Ensure timely submission of Safety Reports to clients, regulatory authorities, and other stakeholders.
Reconcile reports and manage the Affiliate Mailbox to ensure proper documentation and compliance.
Handle written follow-up attempts for adverse event cases.
Collaboration & Communication:
Work closely with your direct supervisor and team members to manage case identification and follow-up tasks.
Communicate effectively with peers, clients, and management to ensure timely and accurate case reporting.
Contribute to the development of new solutions and improvements in the pharmacovigilance processes.
Problem-Solving & Analysis:
Analyze moderately complex issues related to pharmacovigilance and offer solutions.
Adapt existing methods and procedures where necessary to improve processes.
Regulatory Compliance & Quality Control:
Ensure all case processing activities are in line with global regulatory requirements.
Maintain high standards for data quality and regulatory compliance throughout the pharmacovigilance lifecycle.
Team Management:
Potentially manage small teams or work efforts within the pharmacovigilance function, ensuring the team meets objectives and complies with deadlines.
Rotational Shift Work:
Be open to working in rotational shifts as part of the role, ensuring global 24/7 coverage for safety reporting.
What We’re Looking For:
Education & Experience:
Bachelor of Pharmacy (B.Pharm) or MBBS degree.
7 to 11 years of experience in pharmacovigilance and drug safety.
Skills & Abilities:
Strong understanding of pharmacovigilance processes and regulatory requirements.
Proficiency in MedDRA coding and ICSR processing.
Excellent communication skills, both verbal and written.
Ability to solve moderately complex problems and adapt processes.
Experience working in global, multicultural teams and environments.
Language Skills:
English proficiency at an advanced level.
What Accenture Offers:
Global Impact:
Opportunity to work with leading global clients in the life sciences industry.
Contribute to shaping the future of clinical development and patient safety.
Career Development:
Opportunities for growth and development within a global organization.
Access to Accenture’s advanced technology, training programs, and a network of experts in the field.
Work Environment:
Inclusive and diverse workplace culture.
Flexible work arrangements and potential for remote work.
Accenture is committed to providing an inclusive and accessible environment for all candidates. We ensure that our hiring process is free from discrimination and bias, and we encourage candidates from all backgrounds to apply.
If you’re passionate about pharmacovigilance, drug safety, and working with a global team to shape the future of patient safety, apply today to join Accenture!
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