Safety & PV Specialist II - Literature Case Processing

Safety & PV Specialist II - Literature Case Processing

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Job Responsibilities

• Enter information into PV quality and tracking systems for receipt and tracking of ICSRs. Process literature-derived ICSRs according to SOPs and project-specific safety plans. Evaluate case data for completeness, accuracy, and regulatory reportability. Conduct data entry, coding, narrative writing, and follow-up activities as required.
• Perform comprehensive literature screening, review, and Medical Literature Monitoring (MLM) activities to identify and process potential adverse events.
• Maintain safety tracking systems and ensure timely completion of assigned activities and deliverables.
• Conduct MedDRA coding, drug coding, and maintenance of drug dictionaries as required.
• Perform quality review of ICSRs and ensure compliance with project and regulatory requirements.
• Identify, reconcile, and manage duplicate safety cases.
• Support validation and submission activities related to xEVMPD, SPOR, and IDMP requirements.
• Assist with manual recoding of products, substances, and indication terms when required.
• Ensure all relevant safety documentation is maintained and filed appropriately in accordance with company and client requirements.
• Maintain compliance with SOPs, Work Instructions, GVP, ICH-GCP guidelines, global safety regulations, and project-specific procedures.
• Participate in audits, inspections, and quality improvement initiatives as required.
• Apply regulatory intelligence and pharmacovigilance knowledge to safety processing and reporting activities.
• Foster effective working relationships with internal and external stakeholders and contribute to a collaborative team environment.

Qualifications

• 4-7 years of Pharmacovigilance experience, including significant experience in Literature Case Processing and Medical Literature Monitoring (MLM).
• M.Pharm, PharmD, B.Pharm, BDS, or equivalent healthcare-related qualification.
• Strong hands-on experience in ICSR processing, literature surveillance, data entry, narrative writing, and case management.
• Working knowledge of safety databases, MedDRA coding, and medical terminology.
• Good understanding of clinical trials, post-marketing safety requirements, ICH-GCP, GVP, and pharmacovigilance regulations.
• Experience in quality review activities and regulatory compliance processes.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and other collaborative platforms.
• Ability to work independently and effectively within global teams.
• Excellent written and verbal communication skills.
• Strong organizational, analytical, and prioritization skills with the ability to manage multiple activities simultaneously.
• Detail-oriented with a high degree of accuracy and commitment to quality and compliance.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.