Safety & PV Coordinator - Clinical Trial Case Processing (1+ Year Experience)

Syneos Health; India; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Syneos Health is seeking a Safety & PV Coordinator for Clinical Trial Case Processing in India. The role focuses on entering, coding, and tracking ICSRs, maintaining safety databases, and supporting regulatory reporting with strong attention to detail.

The candidate should have 1+ year of experience in pharmacovigilance, a life sciences related degree, and proficiency with safety databases and medical terminology. The position is full-time and on-site in India.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or an equivalent combination of education and experience.
• 1+ years of experience in Clinical Trial Case Processing, including adverse event case handling and pharmacovigilance.
• Experience with Safety Database systems and knowledge of medical terminology.
• Strong understanding of the clinical trial process, ICH-GCP, GVP, and related safety regulations.

Responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• Assist in processing ICSSRs according to SOPs and project-specific safety plans.
• Triages ICSSRs, evaluates ICSR data for completeness and regulatory report ability.
• Enter data into safety database and code events, medical history, and related terms.
• Compile complete narrative summaries and follow up on data queries until resolved.
• Assist in timely, accurate reporting of expedited reports per regulatory requirements.
• Maintain safety tracking for assigned activities and participate in audits as required.
• Ensure submission of relevant documents to TMF and safety system files per SOPs.

Job description

Safety & PV Coordinator - Clinical Trial Case Processing (1+ Year 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.

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

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• Assists in the processing of ICSSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
• Triages ICSSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
• Enters data into safety database.
• Codes events, medical history, concomitant medications, and testsCompiles complete narrative summaries.
• Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
• Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Maintains safety tracking for assigned activities.
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
• Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• Manual recoding of un-recoded product and substance terms arises from ICSSRs.
• Identification and management of duplicate ICSSRs.
• Activities related to SPOR / IDMP.
• Quality review of ICSSRs.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
• Fosters constructive and professional working relationships with all project team members, internal and external.
• Participates in audits as required/appropriate.
• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

Qualifications

• Bachelor's Degree in Life Sciences, Nursing, Pharmacy, or an equivalent combination of education and experience that provides the necessary knowledge, skills, and abilities to perform the job.
• 1 + Years of experience in Clinical Trial Case Processing, including adverse event case handling, safety data review, and pharmacovigilance activities.
• Experience with Safety Database systems and knowledge of medical terminology required.
• Good understanding of the clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH-GCP, GVP, and regulations related to Safety and Pharmacovigilance.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, Outlook, Team Share (or other shared content/workspace management tools), and internet-based applications.
• Ability to work independently and in a team environment.
• Excellent communication and interpersonal skills, both written and verbal.
• Good organizational skills with a proven ability to prioritize and manage multiple tasks and projects simultaneously.
• Detail-oriented with a high degree of accuracy and the ability to meet deadlines.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drug