Safety & PV Specialist I - PQC

Job description

Safety & PV Specialist I - PQC 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** Safety & PV Specialist I - Medical Device & PQC 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 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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. - We are continuously building the company we all want to work for and our customers want to work with. 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** # **Job Title: Safety & Pharmacovigilance Specialist I** **Location:** Gurugram, India (Office-Based) **Employment Type:** Full-Time **Experience Required:** 2.5 – 4 Years ## **Job Summary** The Safety & Pharmacovigilance Specialist I is responsible for end-to-end ICSR processing, safety data management, regulatory reporting support, and compliance with global pharmacovigilance regulations. The role requires demonstrated expertise in Product Quality Complaint (PQC) case handling and experience in medical research safety cases. ## **Key Responsibilities** ### **ICSR Processing & Case Management** - Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs. - Process ICSRs in accordance with Standard Operating Procedures (SOPs) and project/program-specific safety plans. - Triage ICSRs and evaluate case data for completeness, accuracy, and regulatory reportability. - Enter case data into the safety database (Argus / ARISg). - Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and relevant dictionaries. - Prepare comprehensive and medically accurate narrative summaries. - Identify missing or inconsistent information and follow up on queries until satisfactory resolution. - Identify and manage duplicate ICSRs. - Perform quality review of ICSRs. ### **Regulatory Reporting & Compliance** - Assist in the preparation and submission of timely, consistent, and accurate expedited safety reports in accordance with global regulatory requirements. - Validate and submit xEVMPD product records, including appropriate MedDRA coding of indication terms. - Perform manual recoding of un-coded product and substance terms arising from ICSRs. - Support SPOR / IDMP-related activities. - Maintain safety tracking for assigned activities. - Ensure all relevant documents are submitted to the Trial Master File (TMF) for clinical trials and the Pharmacovigilance System Master File (PSMF) for post-marketing programs, as applicable. - Apply safety reporting regulatory intelligence to all safety reporting activities. ### **Literature, Audit & Collaboration** - Perform literature screening and safety review. - Maintain drug dictionaries and support coding activities. - Maintain compliance with SOPs, Work Instructions (WIs), GCP, ICH guidelines, GVP, and global drug/biologic/device regulations. - Participate in audits and support inspection readiness. - Foster constructive