Syneos Hiring Pharmacy Graduates for PV Role
Are you looking for a Pharmacovigilance Job in Hyderabad? Syneos Health is hiring immediate joiners for the position of Safety & PV Coordinator. Candidates with a BPharm or MPharm qualification and a minimum of one year of experience in post-marketing surveillance and spontaneous case processing can apply.
The selected candidate will support individual case safety report processing, safety-database management, medical coding, literature screening, regulatory reporting, and other pharmacovigilance activities.
- Job Title: Safety & PV Coordinator
- Company: Syneos Health
- Location: Hyderabad
- Work Arrangement: Office-based
- Qualification: BPharm or MPharm
- Experience: Minimum one year
- Preferred Candidates: Immediate joiners
- Required Experience: PMS and spontaneous case processing
- Preferred Database: LSMV; candidates with Argus experience may also be considered
About Syneos Health
Syneos Health is a fully integrated life-sciences services organization that works with innovators across the drug-development and commercialization continuum. The company combines clinical development expertise with commercial capabilities to help customers navigate complexity and accelerate progress.
Its Clinical Solutions professionals apply extensive experience and therapeutic knowledge to understand customer requirements and develop effective solutions. Employees may work within a Functional Service Provider partnership or a full-service environment while collaborating with global project teams.
Job Description
The Safety & PV Coordinator will support the receipt, evaluation, processing, tracking, quality review, and regulatory reporting of Individual Case Safety Reports. This Syneos Health pharmacovigilance job also involves safety-database activities, MedDRA coding, literature screening, duplicate-case management, and pharmacovigilance documentation.
Candidates must understand clinical-trial and post-marketing safety requirements and work in accordance with applicable SOPs, work instructions, global regulations, ICH-GCP, and Good Pharmacovigilance Practices.
Key Responsibilities
- Enter information into pharmacovigilance quality and tracking systems for the receipt and tracking of ICSRs.
- Assist in processing ICSRs according to SOPs and project- or program-specific safety plans.
- Triage safety cases and evaluate ICSR data for completeness, accuracy, and regulatory reportability.
- Enter case information into the applicable safety database.
- Code adverse events, medical history, concomitant medications, tests, and other relevant case information.
- Compile complete and accurate narrative summaries.
- Identify missing information and raise follow-up queries until the required information is obtained and satisfactorily resolved.
- Support the timely and accurate submission of expedited safety reports according to applicable regulatory requirements.
- Maintain safety tracking records for assigned activities.
- Perform literature screening and safety-review activities.
- Support drug coding, drug-dictionary maintenance, and MedDRA coding.
- Validate and submit xEVMPD product records, including the appropriate coding of indication terms using MedDRA.
- Perform manual recoding of unrecoded product and substance terms arising from ICSRs.
- Identify and manage duplicate ICSRs.
- Support activities associated with SPOR and IDMP.
- Conduct quality reviews of ICSRs.
- Ensure that relevant documents are submitted to the Trial Master File for clinical trials.
- Maintain appropriate documentation in the Pharmacovigilance System Master File for post-marketing programs.
- Remain compliant with company SOPs, work instructions, GCP, ICH guidelines, GVP, global safety regulations, project plans, and the drug-development process.
- Build constructive and professional working relationships with internal and external project-team members.
- Participate in audits whenever required.
- Apply Syneos Health’s safety-reporting regulatory intelligence to assigned pharmacovigilance activities.
Eligibility Criteria
- Educational Qualification: BPharm or MPharm only
- Experience: Minimum one year of relevant experience
- Mandatory Experience: PMS and spontaneous case processing
- Work Location: Hyderabad office
- Joining Requirement: Immediate joiners preferred
Required Skills
- Experience working with pharmacovigilance safety databases.
- LSMV experience is preferred; candidates with Argus experience may also be considered.
- Knowledge of medical terminology.
- Understanding of the clinical-trial process across Phases II–IV and/or post-marketing safety requirements.
- Knowledge of ICH-GCP, GVP, and regulations related to drug safety and pharmacovigilance.
- Understanding of ICSR processing, medical coding, narrative writing, and regulatory reporting.
- Proficiency in Microsoft Word, Excel, PowerPoint, Visio, Outlook, and shared workspace or content-management tools.
- Ability to work independently and collaboratively in a team environment.
- Excellent written and verbal communication skills.
- Strong organizational and time-management abilities.
- Ability to prioritize and manage multiple tasks and projects.
- High attention to detail and accuracy.
- Ability to complete assigned activities within established deadlines.
Why Join Syneos Health?
Syneos Health supports employee development through career-progression opportunities, technical and therapeutic-area training, engaged line management, peer recognition, and total-rewards programs.
The company promotes an inclusive work environment where employees can collaborate with experienced professionals from around the world. Syneos Health reports that, over five years, it has worked with 94% of novel FDA-approved drugs, 95% of EMA-authorized products, and more than 200 studies across 73,000 sites involving over 675,000 trial participants.
Apply for the Syneos Health Pharmacovigilance Job
This Syneos Health pharmacovigilance job is an excellent opportunity for BPharm and MPharm candidates with experience in PMS, spontaneous cases, and safety-database operations. Eligible professionals who can join immediately and work from the Hyderabad office are encouraged to apply at the earliest.
CLICK HERE TO APPLY ONLINE
Pharmanika is a career information portal. Candidates should verify the eligibility requirements, application process, job availability, and other details through the official Syneos Health job notification before applying.
