Pharmacovigilance Jobs at Syneos Health Careers – Safety & PV Specialist I
Pharmacovigilance Jobs at Syneos Health Careers provide an excellent opportunity for experienced safety professionals to work with a globally integrated biopharmaceutical organization. The Safety & PV Specialist I role focuses on ICSR processing, regulatory compliance, and clinical safety activities, making it a strong career move for professionals seeking growth through Syneos Health Careers in Gurugram or Hyderabad.
Job Details
- Job Title: Safety & PV Specialist I
- Location: Gurugram / Hyderabad
About the Company
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. With respect to Pharmacovigilance Jobs, Syneos Health continues to gain recognition in the industry.
The Clinical Development model brings the customer and the patient to the center of everything that we do. Speaking of opportunities, many Pharmacovigilance roles and jobs enable professionals to contribute meaningfully. 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.
Job Description
Roles within the Pharmacovigilance & Safety job family are responsible for providing expertise on pharmacovigilance services. This includes participating in all aspects of the medical safety team’s involvement in assigned trials, such as performing medical review and clarification of trial-related Adverse Events, providing aggregate reviews of safety information, and serving as an internal consultant to pharmacovigilance case processing teams. In the context of Pharmacovigilance Jobs, these responsibilities support both team and organizational safety objectives.
Provides and contributes trends, safety signal detection, and risk management assessment, and provides safety support to the clinical development teams. For those seeking jobs within Pharmacovigilance, this is a critical function.
Key Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs as required. In Pharmacovigilance, jobs often demand acute attention to data entry accuracy.
- Assist in the processing of ICSRs according to SOPs and project/program-specific safety plans
- Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability
- Enter data into the safety database and code events, medical history, concomitant medications, and tests, as is expected in most jobs dealing with Pharmacovigilance processes.
- Compile complete narrative summaries
- Identify information to be queried and follow up until queries are satisfactorily resolved
- Assist in the generation of timely, consistent, and accurate expedited reports
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety and drug coding
- Validation and submission of xEVMPD product records using MedDRA
- Manual recoding of unrecoded product and substance terms arising from ICSRs
- Identification and management of duplicate ICSRs
- Activities related to SPOR / IDMP
- Quality review of ICSRs
- Ensure submission of documents to the TMF and the Pharmacovigilance System Master File
- Maintain compliance with SOPs, WIs, GCP, ICH, GVP, and global regulations
- Foster professional working relationships with internal and external teams
- Participate in audits as required
- Apply safety reporting regulatory intelligence maintained by Syneos Health
Qualifications
- B.Pharm / M.Pharm / PharmD
- Minimum 2 years of experience is needed for most jobs in Pharmacovigilance roles.
- Preferred CT case processing or literature case processing experience
- Strong pharmacovigilance knowledge
- Knowledge of safety database systems and medical terminology
- Understanding of clinical trial processes (Phases II–IV) and post-marketing safety
- Knowledge of ICH GCP, GVP, and safety regulations
- Proficiency in Microsoft Office Suite, Visio, Outlook, and shared workspaces is a plus for any Pharmacovigilance career path or jobs in the field.
- Ability to work independently and in a team environment
- Excellent written and verbal communication skills
- Strong organizational and multitasking abilities are highly valued in Pharmacovigilance jobs at every level.
- close attention to detail with the ability to meet deadlines
