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 ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
- Triages ICSRs, 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 ICSRs.
- Identification and management of duplicate ICSRs.
- Activities related to SPOR / IDMP.
- Quality review of ICSRs.
- 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 Office based
Experience:
Safety & PV Specialist ll : 4 years - 7 years.
-Immediate joiners will be preferred
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
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.com
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.
Skills Required
- B. Pharm / M. Pharm / BDS / BMS / MBBS (No BSc / MSc)
- 4-7 years pharmacovigilance/safety experience
- Experience with ICSR processing and entry into safety databases (PVG or equivalent)
- MedDRA coding experience
- Experience with xEVMPD product record validation and submission
- Experience with SPOR / IDMP activities
- Literature screening and safety signal review experience
- Knowledge of GCP, ICH, GVP, SOPs and regulatory reporting requirements
- Experience maintaining Trial Master File (TMF) and Pharmacovigilance System Master File
- Ability to compile narrative summaries, identify queries, resolve information gaps, and perform ICSR quality review
- Identification and management of duplicate ICSRs
- Office-based in Gurugram or Hyderabad
- Immediate joiners preferred
Syneos Health Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Syneos Health and has not been reviewed or approved by Syneos Health.
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Leave & Time Off Breadth — Unlimited PTO for managers and flexible time‑off options make time away accessible and support work‑life balance. Day‑to‑day usability can depend on team and workload, but the policy breadth is a clear strength.
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Retirement Support — A 401(k) with company match is frequently highlighted as a strong component of the package. Despite vesting details to confirm, the retirement offering adds meaningful long‑term value.
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Parental & Family Support — Partnership with Maven provides fertility, adoption support, parental‑leave guidance, and women’s health resources across multiple regions. This family‑building support enhances the overall total rewards appeal.
Syneos Health Insights
What We Do
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. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.
