Safety & PV Coordinator (Submission Team) | 1+ Year PV Experience

Safety & PV Coordinator (Submission Team) | 1+ Year PV Experience

Safety & PV Coordinator (Submission Team) | 1+ Year PV Experience

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 Individual Case Safety Reports (ICSRs).
• Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.
• Triage ICSRs and evaluate case data for completeness, accuracy, and regulatory reportability.
• Perform data entry into safety databases.
• Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and relevant coding dictionaries.
• Compile complete and accurate case narratives.
• Identify missing information, generate queries, and ensure timely follow-up and resolution.
• Support the timely and accurate reporting and submission of expedited safety reports.
• Maintain safety tracking and documentation for assigned activities.
• Perform literature screening and review for safety information.
• Conduct MedDRA coding, drug coding, and maintenance of safety databases and dictionaries.
• Support validation and submission activities, including xEVMPD product records and indication coding.
• Identify and manage duplicate ICSRs.
• Support SPOR/IDMP-related activities, as applicable.
• Perform quality review of ICSRs and related safety documentation.
• Ensure all relevant documents are maintained in accordance with company SOPs, regulatory requirements, and project needs.
• Maintain compliance with SOPs, Work Instructions, GVP, ICH Guidelines, GCP, and global pharmacovigilance regulations.
• Collaborate effectively with internal and external stakeholders.
• Participate in audits and inspections as required.

Qualifications

• B.Pharm / M.Pharm / BDS / M.Sc / Pharm D required.
• Minimum 1 year of Pharmacovigilance experience.
• Hands-on experience in ICSR processing, case intake, data entry, coding, submissions, and/or quality review preferred.
• Knowledge of MedDRA coding and global PV regulations.
• Strong attention to detail and excellent communication skills.
• Ability to work effectively in a fast-paced, team-oriented environment.
• Only immediate joiners or candidates serving a notice period of up to 30 days will be considered.

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.