Are you a life science graduate with a passion for patient safety and a keen eye for detail? Pharmabharat brings you exciting career opportunities with Syneos Health, a leading global biopharmaceutical solutions organization. Syneos Health is actively seeking talented individuals to join their Pharmacovigilance team in Pune, India, for the roles of Safety & PV Coordinator and Safety & Pharmacovigilance Specialist I. If you’re looking to contribute to a company that’s dedicated to accelerating the delivery of therapies and improving lives, this could be your perfect opportunity!
Why Syneos Health?
Syneos Health distinguishes itself as a company committed to employee growth and fostering a supportive work environment. They understand that their employees are their greatest asset, offering various programs and initiatives to promote career development, well-being, and a sense of belonging. Here’s why you should consider a career at Syneos Health:
- Career Growth:Â Syneos Health prioritizes the development of its employees through career progression opportunities, engaged line management, and specialized training programs.
- Total Self Culture:Â They promote a culture where you can authentically be yourself, embracing diversity and fostering an inclusive work environment.
- Innovation and Impact:Â Collaborate with passionate problem-solvers and contribute to the development and delivery of life-changing therapies.
Available Positions:
Syneos Health is currently hiring for the following roles in Pune:
- Safety & PV Coordinator
- Safety & Pharmacovigilance Specialist I
Let’s dive into the specifics of each role.
1. Safety & PV Coordinator
Location: Pune, India
Responsibilities:
As a Safety & PV Coordinator, you will play a crucial role in ensuring the smooth and efficient management of safety information. Your key responsibilities will include:
- Monitoring and routing incoming safety information to the appropriate projects.
- Recording and tracking ICSR (Individual Case Safety Report) documentation.
- Redacting patient identifying information in compliance with data protection guidelines.
- Entering data into the safety database accurately and efficiently.
- Managing translation processes for source documents.
- Assisting with query follow-up and submission processes.
- Contributing to literature screening and review for safety information.
- Supporting the generation of timely and accurate expedited reports.
- Ensuring all relevant documents are submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File.
Qualifications:
- Bachelor’s Degree in life science, registered nurse, pharmacist, or equivalent.
- Familiarity with safety database systems and medical terminology (preferred).
- Proficiency in Microsoft Office Suite.
- Strong organizational, communication, and interpersonal skills.
- Detail-oriented with a high degree of accuracy.
2. Safety & Pharmacovigilance Specialist I
Location: Pune, India
Responsibilities:
As a Safety & Pharmacovigilance Specialist I, you will be responsible for processing and managing Individual Case Safety Reports (ICSRs) and ensuring compliance with regulatory requirements. Your key responsibilities will include:
- Entering information into PVG quality and tracking systems for receipt and tracking ICSR as required.
- Processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
- Triaging ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
- Entering data into safety database.
- Coding events, medical history, concomitant medications, and tests.
- Compiling complete narrative summaries.
- Identifying information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Assisting in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Maintaining safety tracking for assigned activities.
- Performing 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 ICSRs.
- Identification and management of duplicate ICSRs.
- Activities related to SPOR / IDMP.
- Quality review of ICSRs.
Qualifications:
- Bachelor’s Degree in life science, registered nurse, pharmacist, or equivalent.
- Familiarity with safety database systems and 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.
- Excellent communication and interpersonal skills.
- Strong organizational skills with the ability to prioritize and manage multiple tasks.
- Detail-oriented with a high degree of accuracy and ability to meet deadlines.
Application Link For Safety & PV Coordinator
Application Link For Safety & Pharmacovigilance Specialist I
