Safety & Pharmacovigilance Coordinator (1+ Year Experience in CT or Literature Data Entry)

5264 Syneos Health India Private Limited; Gurugram District; On-site; INR 400,000 - 640,000; Full time

Job summary

Syneos Health is seeking a Safety & Pharmacovigilance Coordinator with 1+ year of CT or literature data entry experience in our India operations. You will monitor safety information, route it to teams, redact identifiers, and ensure compliant data entry into safety databases.

The role requires B.Pharm/ M.Pharm/ PharmD / BDS and strong organizational skills. You will support translation processes, handle queries, and assist with daily workflow reconciliation while adhering to ICH-GCP and GVP

Qualifications

• Healthcare professional by education: B.Pharm / M.Pharm / PharmD / BDS.
• Minimum 1 year of experience in Pharmacovigilance in a full data entry / case processing role is mandatory.
• Experience in processing Literature and Clinical Trial (CT) cases is preferred.
• Experience with safety database systems and medical terminology preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, TeamShare (or similar document management systems).
• Strong ability to work collaboratively as part of a team.

Responsibilities

• Monitor and route incoming safety information to the appropriate project teams.
• Record all ICSR documentation and track cases in accordance with sponsor/customer specifications; distribute incoming mail and faxes.
• Redact patient-identifying information and images in compliance with data protection guidelines, ICH-GCP, and GVP requirements.
• Perform accurate and timely data entry into the safety database in accordance with customer-specific guidelines and company standards.
• Assist with case file creation, tracking, retention, and maintenance (paper and electronic).
• Support management of translation processes for source documents requiring translation.
• Assist with query follow-up activities as instructed.
• Support safety submission processes as instructed.
• Assist with daily workflow reconciliation activities.

Skills

Communication skills

Teamwork

Organizational skills

Attention to detail

Time management

Education

B.Pharm / M.Pharm / PharmD / BDS

Tools

Microsoft Office Suite

Visio

Outlook

PowerPoint

TeamShare

Job description

Safety & Pharmacovigilance Coordinator (1+ Year Experience in CT or Literature Data Entry) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. 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 accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Monitor and route incoming safety information to the appropriate project teams.
• Record all ICSR documentation and track cases in accordance with sponsor/customer specifications; distribute incoming mail and faxes.
• Redact patient-identifying information and images in compliance with data protection guidelines, ICH-GCP, and GVP requirements.
• Perform accurate and timely data entry into the safety database in accordance with customer-specific guidelines and company standards.
• Assist with case file creation, tracking, retention, and maintenance (paper and electronic).
• Support management of translation processes for source documents requiring translation.
• Assist with query follow-up activities as instructed.
• Support safety submission processes as instructed.
• Assist with daily workflow reconciliation activities.
• Maintain a working knowledge of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP modules, study/program plans, and the drug development process.

Qualification Requirements

• Healthcare professional by education: B.Pharm / M.Pharm / PharmD / BDS.
• Minimum 1 year of experience in Pharmacovigilance in a full data entry / case processing role is mandatory.
• Experience in processing Literature and Clinical Trial (CT) cases is preferred.
• Experience with safety database systems and medical terminology preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, TeamShare (or similar document management systems), and internet applications.
• Strong ability to work collaboratively as part of a team.
• Ability to prioritize and manage multiple tasks effectively in a fast-paced environment.
• Excellent written and verbal communication and interpersonal skills.
• Strong organizational and documentation skills with high attention to detail and accuracy.
• Should be flexible to work in rotational shifts.

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.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.