Syneos Health, a globally renowned biopharmaceutical solutions organization, is on the lookout for a dynamic Safety & Pharmacovigilance Specialist I to join their team in Gurugram, India. This position plays a vital role in processing and monitoring Individual Case Safety Reports (ICSRs) to ensure regulatory compliance and patient safety. Here is an in-depth look at the job responsibilities, qualifications, and application process.
About Syneos Health
Syneos Health is committed to transforming biopharmaceutical success through integrated clinical development, medical affairs, and commercial insights. With a presence in over 110 countries and a diverse team of 29,000 professionals, Syneos Health is driven to deliver innovative solutions and improve patient outcomes. The organization fosters a culture of inclusion and offers robust career development opportunities for its employees.
Key Responsibilities
As a Safety & Pharmacovigilance Specialist I, your responsibilities will include:
- ICSR Management: Processing ICSRs, ensuring accuracy, completeness, and adherence to regulatory requirements.
- Data Entry & Tracking: Maintaining quality and tracking systems for ICSRs, entering data into safety databases, and coding events, medical history, and concomitant medications.
- Narrative Summaries & Queries: Compiling comprehensive narrative summaries, identifying incomplete information, and resolving queries.
- Regulatory Reporting: Generating expedited reports for regulatory submission in compliance with applicable regulations.
- Medical Coding & Literature Review: Conducting literature screenings, performing MedDRA coding, and managing drug dictionaries.
- Quality Assurance: Ensuring the accuracy of ICSRs, maintaining safety tracking, and participating in audits.
- Regulatory Compliance: Staying updated with global regulatory guidelines, including GCP, ICH, GVP, and other safety reporting standards.
- Collaboration & Documentation: Collaborating with project teams, ensuring proper documentation in Trial Master Files (TMFs), and fostering professional relationships with internal and external stakeholders.
Qualifications
To be successful in this role, candidates must meet the following criteria:
- Educational Background: Bachelor’s degree in life sciences, pharmacy, or nursing, or an equivalent combination of education and experience.
- Technical Expertise: Proficiency in safety database systems and medical terminology.
- Regulatory Knowledge: Strong understanding of clinical trial processes, safety requirements for Phases II-IV, and post-marketing regulations.
- Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, and other management tools.
- Soft Skills: Excellent communication, organizational, and interpersonal skills with attention to detail and the ability to meet deadlines.
Desired Skills
- Ability to work both independently and collaboratively in a team environment.
- Strong analytical skills with a focus on accuracy and efficiency.
- Knowledge of xEVMPD product records, MedDRA coding, and duplicate management in safety reporting.
- Familiarity with SPOR/IDMP activities and pharmacovigilance regulatory intelligence.
