Pharmacovigilance Services Specialist

Pharmacovigilance Services Specialist

Skill required: Pharmacovigilance Operations - Safety Writing
Designation: Pharmacovigilance Services Specialist
Qualifications:Any Graduation
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 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? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Pharmacovigilance Operations involve monitoring and assessing the safety of pharmaceutical products. This includes detecting, evaluating, and preventing adverse effects or any other drug-related problems. The goal is to ensure that medications are safe for patients and to comply with regulatory requirements. These operations involve collecting and analyzing data from clinical trials, healthcare providers, and patients. Effective pharmacovigilance is crucial for protecting public health and maintaining trust in medical products. Manage and develop individual case narratives describing adverse events for inclusion in regulatory submissions and safety reports for completed/interim clinical study reports.
What are we looking for? • Bachelor/master’s degree or above in pharmacy/life sciences. • 9 - 12 years of relevant experience in reviewing Medical Documents/Medical Referencing. • Proficiency in medical referencing techniques and awareness of industry standards. • Exhibit proficiency in MS Office applications, including Excel, Adobe Acrobat, Outlook, and PowerPoint. • Strong organizational skills and attention to detail. • Effective interpersonal and communication skills. • Ability to work well in a dynamic team environment. • Experience with Veeva Vault PromoMats/Vault ProMotion is preferred.
Roles and Responsibilities: • Ensure that team functions are aligned to meet service level timelines and deliverables. • Ensure availability of resources within the team and develop strategies and plans to utilize resources to effectively and efficiently. • Evaluate team members work for performance improvement. • Serve as a point of contact for client and Accenture • Ensure quality delivery and client engagement for organic growth. • Identify and support continuous improvement initiatives • Use scientific expertise to develop high-quality medical/scientific content outlines and guide the team in content development for assigned modules/projects in line with client expectations. • Collaborate with cross-functional teams to support the medical/legal/regulatory (MLR) review process, respond to MLR review committee queries, and implement required changes effectively. • Write scientific content for projects if the nature of the project is extremely complex and it requires expertise or based on business need. • Communicate the clinical data in a clear and concise manner. • Follow department best practices for processes, communication, project management, documentation, and technical requirements. • Converts relevant data and information into a form that meets regional regulatory requirements. • Understands and complies with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and SOPs to comply with regulatory requirements. • Ensure compliance with client and Accenture internal SOPs for all materials. • Collaborate with technology and creative teams to develop innovative digital solutions. • Participate in client pitches and business development meetings. • Train and mentor writers, contributing to skill development. • Please note that this role may require you to work in rotational shifts