Safety & PV Coordinator (Hyderabad Office-based) - Immediate Joiners

Syneos Health; India; On-site; INR 400,000 - 700,000; Full time

Job summary

Syneos Health Hyderabad office is seeking a Safety & PV Coordinator to support pharmacovigilance activities, data entry into PV systems, and ICSR processing for immediate joiners.

You will triage ICSR, code events, maintain safety tracking, perform literature screening, and ensure compliance with SOPs, GVP, ICH guidelines, and post-marketing safety requirements.

Qualifications

• Must have B.Pharm or M.Pharm degree.
• Experience in PMS and spontaneous cases preferred.
• Good understanding of pharmacovigilance and safety processes.

Responsibilities

• Enter information into PVG quality and tracking systems for ICSR processing.
• Triages ICSR and ensures data completeness and regulatory reportability.
• Maintain safety tracking and submit reports per SOPs and regulations.
• Perform literature screening and MedDRA coding as required.
• Support SPOR/IDMP activities and TMF documentation.

Skills

MS Office

Communication

Teamwork

Independence

Education

B.Pharm/M.Pharm

Tools

LSMV

Argus

Job description

Safety & PV Coordinator (Hyderabad Office-based) - Immediate Joiners

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

Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSR according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSR, 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 ICSR.

Identification and management of duplicate ICSR.

Activities related to SPOR / IDMP.

Quality review of ICSR.

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

• Education: B.Pharm/M.Pharm only
• Office Location: Hyderabad
• Experience: Minimum 1 year of experience in PMS and Spontaneous cases
• Preferred Database: LSMV, fine to proceed with Argus
• Safety Database systems and knowledge of medical terminology required.
• Good understanding of 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, email (Outlook), Team Share (or another management/shared content/workspace) and internet.
• Ability to work independently and in a team environment.
• Excellent communication and interpersonal skills, both written and spoken.
• Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
• Detail oriented with a high degree of accuracy and ability to meet deadlines.

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 highl