Safety & PV Specialist- Future Roles (India)

Syneos Health, Inc.; India; On-site; INR 600,000 - 900,000; Full time

Job summary

Syneos Health, Inc. in India is seeking a Safety & PV Specialist to support pharmacovigilance activities, including IC/ICSR processing, MedDRA coding and safety record maintenance. You will work with global teams to ensure compliance with GVP/ICH guidelines and company SOPs.

Ideal candidates hold a life science degree, have strong communication skills, and are proficient with safety databases and MS Office. The role involves cross-functional collaboration and adherence to regulatory timelines.

Qualifications

• Bachelor's Degree in life science, nursing, pharmacy or equivalent.
• Safety Database systems and knowledge of medical terminology required.
• Strong understanding of clinical trial processes and safety regulations.
• Proficiency with Microsoft Office and basic IT tools.
• Ability to work independently and in a team.
• Excellent written and spoken communication and organization.

Responsibilities

• Enter information into PVG quality and tracking systems for IC/ICSR processing as required.
• Maintain safety tracking for assigned activities.
• Perform literature screening and safety reviews, MedDRA coding as needed.
• Validate and submit xEVMPD product records with proper indication coding.
• Recoding of un-coded product terms from IC records.
• Identify and manage duplicate IC entries and SPOR/IDMP activities.
• Provide QA review of IC data and ensure TMF/SOP compliance.
• Maintain compliance with SOPs, ICH/GCP, GVP and drug safety regulations.
• Foster professional relationships across project teams and participate in audits.

Skills

Communication skills

Teamwork

Detail-oriented

Organizational skills

Microsoft Office

Education

Bachelor's degree in life science or related field

Tools

MedDRA coding

Job description

Safety & PV Specialist- Future Roles (India)

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? Because 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 IC

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 IC

Identification and management of duplicate IC

Activities related to SPOR / IDMP.

Quality review of IC

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

• Bachelor's Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.
• Safety Database systems and knowledge of 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 (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.
• Ability to work independently and in a team environment.
• Excellent communication and interpersonal skills, both written and spoken.
• Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
• Detail oriented with a high degree of accuracy and ability to meet deadlines.

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.

http://www.syneoshealth.