Safety & PV Specialist I & II

Syneos Health, Inc.; Gurgaon; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Syneos Health is seeking Safety & PV Specialists (I & II) for our Gurgaon-Hyderabad office. The role focuses on PV data management, ICSR processing, and regulatory reporting, with emphasis on accuracy, SOP adherence, and timely completion.

Immediate joiners are preferred as the team supports global pharmacovigilance programs. Qualified candidates will have a pharmacovigilance background, a pharmacy/medical degree, and experience in safety databases and MedDRA coding.

Qualifications

• Education: B. Pharm / M. Pharm / BDS / BMS / MBBS (No BSc / MSc)
• Location: Gurugram-Hyderabad Office-based
• Experience: Safety & PV Specialist I - Minimum 2.6 Years; II - Minimum 4 Years
• Immediate joiners preferred

Responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• Assists in the processing of ICSR according to SOPs and project safety plans as required.
• Triages ICSR, evaluates data for completeness, accuracy, and regulatory report ability.
• Enters data into safety database.
• Codes events, medical history, concomitant medications, and tests.
• Compiles complete narrative summaries.
• Identifies information to be queried and follows up until information is obtained.

Education

B. Pharm / M. Pharm / BDS / BMS / MBBS (No BSc / MSc)

Tools

MedDRA coding

Safety database entry

Job description

Updated: Today
Location: Gurgaon, India
Job ID:25110715

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.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

Discover what our 29,000 employees, across 110 countries already know.

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

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 tests.

- Compiles 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 / BDS / BMS / MBBS (No BSc / MSc)

Location: Gurugram-Hyderabad Officebased

Experience-

Safety & PV Specialist l- Minimum 2.6 Years

Safety & PV Specialist ll- Minimum 4 Years

-Immediate joiners will be preferred

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 highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

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.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your pastexperience doesn’t align perfectly, we encourage you to apply anyway. At times, we take intoconsideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health® (Nasdaq: SYNH) is a leading integrated biopharmaceutical solutionsorganization built to accelerate customer success. We translate unique clinical,medical affairs and commercial insights into outcomes to address modern marketrealities. Together we share insights, use the latest technologies and applyadvanced business practices to speed our customers’ delivery of importanttherapies to patients. We support a diverse, equitable and inclusive culture.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receiveconsideration for employment without regard to race, color, age, religion, marital status,ethnicity, national origin, sex, gender, gender identity, sexual orientation, protectedveteran status, disability or any other legally protected status and will not bediscriminated against. If you are an individual with a disability who requires reasonableaccommodation to complete any part of our application process, including the use of thiswebsite, please contact us at: Email: [e-mail] One of our staff members will workwith you to provide alternate means to submit your application.

Safety & PV Specialist I & II

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.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

Discover what our 29,000 employees, across 110 countries already know.

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

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 tests.

- Compiles 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 / BDS / BMS / MBBS (No BSc / MSc)

Location: Gurugram-Hyderabad Officebased

Experience-

Safety & PV Specialist l- Minimum 2.6 Years

Safety & PV Specialist ll- Minimum 4 Years

-Immediate joiners will be preferred