FSP Clinical Scientist Job at Syneos Health
Syneos Health is hiring an FSP Clinical Scientist in Pune, Maharashtra, to support medical and scientific data review for hematology clinical trials. This Scientist Job role is ideal for life sciences professionals with strong clinical research expertise who want to contribute to high-impact global drug development programs. Graduates seeking PharmD Jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: FSP Clinical Scientist
- Location: Pune, Maharashtra, India
About the Company
Syneos Health is a leading fully integrated biopharmaceutical solutions organization, operating across 110 countries with over 29,000 employees. The company supports clinical development, medical affairs, and commercialization, having worked on the majority of recent FDA-approved and EMA-authorized products. Syneos Health is driven by a patient-centric, innovation-focused culture dedicated to changing lives through better therapies.
Educational Requirements
- Degree in PharmD
- Equivalent scientific experience or training will also be considered
Key Responsibilities
- Perform medical and scientific data review for hematology clinical trials.
- Conduct standard data listing reviews, including adverse events and concomitant medications.
- Review patient profiles, efficacy data, safety narratives, and pharmacodynamic data.
- Support the Lead Clinical Scientist with scientific data reviews.
- Develop and support Medical Management Plans, Medical Data Review Plans, and Eligibility Review Plans in collaboration with Medical Directors.
- Perform regular and ad-hoc medical data reviews using listings and data visualizations.
- Identify data risks, trends, and patterns and support documentation of findings.
- Author medical data queries, review responses, and approve query closure.
- Assist with protocol deviation review and preparation of medical review summary reports.
- Support medical data review and safety review meetings, including slide preparation.
- Collaborate with cross-functional teams, including Clinical Operations, Data Management, Drug Safety, Pharmacovigilance, and Project Management.
- Ensure adherence to ICH, GCP, data privacy regulations, SOPs, and enterprise policies.
- Participate in internal and external audits and trusted process meetings.
Skills Required
- Strong understanding of clinical research and scientific principles.
- Experience in medical and scientific data review.
- Knowledge of hematology clinical trials is preferred.
- Proficiency in ICH-GCP guidelines and regulatory requirements.
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple tasks in a fast-paced, regulated environment.
- Proficiency in MS Office tools, including spreadsheets and presentations.
- Strong teamwork and cross-functional collaboration skills.
- Graduates seeking PharmD Jobs or Pharmacy jobs can apply now.
