Principal Safety
6 days ago
**Description**
**Principal Safety & Pharmacovigilance Specialist**
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
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**
- Works independently to oversee day to day Safety and Pharmacovigilance (SPVG) activities on assigned projects/programs.
- Exercises independent judgement to troubleshoot and resolve project issues and to identify areas for improvement.
- Develops innovative solutions to meet unique, client-specific requirements.
- Supports management/lead in reviewing and presenting prepared information at project or departmental review meetings.
- Develops training materials, conducts training presentations and on-the-job-training for appropriate departmental teams.
- Participates in and/or leads departmental initiatives to increase efficiencies and optimize processes.
- Presents at client/investigator meetings.
- Assists in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs). Proposes solutions to issues that may arise and strategies to improve metrics/cycle times.
- Participate in audits/inspections as the SPVG SME.
- Maintains understanding and compliance with SOPs, WIs, global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, study/program plans and the drug development process.
**Qualifications**
**What we’re looking for**
- 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 experience and knowledge of medical terminology required
- Excellent understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP and regulations related to Safety and Pharmacovigilance
- Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff members
- Demonstrates initiative on the individual and team level; ability to work effectively within a team to attain a shared goal
- Strong organizational skills with proven ability to handle multiple tasks
- Strong presentation, documentation, and interpersonal skills
- Ability to deliver high quality work in a dynamic environment
- Minimal travel may be required (10%)
**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 obli
-
Vice Principal
4 weeks ago
India Aga Khan Education Services Full timeThe position This opening is for Diamond Jubilee High School, Mumbai (DJHSM), under the flagship of the Aga Khan Education Service, India (AKESI). Since 2012, DJHSM has been a co-educational institution following the Indian Certificate of Secondary Education (ICSE) curriculum. It offers classes from Nursery to Grade 10. The Vice-Principal is the second...
-
Principal
3 weeks ago
India Bharti Foundation Full time**Band** - 1**Department/Function** - Senior Secondary**Location City** - Chowgawa**State** - Punjab**Region** - 1**Reporting to (Designation/Role)** - DGM-Program**Reported by (Designation/Role)** **Ideal Age Bracket** - 35-45 Years**Qualification** - Full-time master degree in any discipline from a recognized University. - B.Ed. (Full time) from a...
-
Technical Risk
2 weeks ago
Delhi, India Environmental Resources Management (ERM) Full timeJob Description Technical Risk & Safety Principal Consultant ERM is looking for motivated, commercial driven Principal Consultant to join our Liability Portfolio Management & Remediation (LPMR) team in New Delhi, Mumbai or Bangalore. The ideal candidate will bring significant consulting and project management experience to provide technical leadership,...
-
Principal Investigator
2 weeks ago
Bengaluru, India Syngene International Limited Full timeJob Description Title: Principal Investigator / Sr Principal Investigator Date: 4 Feb 2025 Job Location: Bangalore Pay Grade Year of Experience: Job Description Designation: Principal Investigator / Sr Principal Investigator- Discovery Chemistry (Level-6) Job Location: Hyderabad Department: Discovery Chemistry Position Summary We are looking for a...
-
Drug Safety Physician
1 day ago
India Katalyst Healthcares & Life Sciences Full time**Responsibilities**: - Monitor patient safety during clinical trials by reviewing adverse events, SAEs, and providing medical assessments. - Ensure timely and accurate reporting of SAEs and safety signals to regulatory authorities. - Provide medical expertise to clinical study teams, investigators, and safety personnel for safety - related queries and...
-
Principal Investigator
4 weeks ago
Bengaluru, India Syngene International Limited Full timeJob Description Title: Principal Investigator Date: 7 Jan 2025 Job Location: Bangalore Pay Grade Year of Experience: Job Description Designation: Principal Investigator - Discovery Chemistry Job Location: Hyderabad Department: Discovery Chemistry Position Summary We are looking for a highly experienced Synthetic Chemists at Group leader level....
-
Principal Statistician
2 weeks ago
India Cytel, India Full timeOur commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together...
-
Vice principal
3 weeks ago
Bhopal, India EducoHire Full timeJob Description Job Title: Vice Principal Reports to: Principal Job Overview: The Vice Principal assists the Principal in the management and administration of the school. The role requires ensuring the smooth running of academic and non-academic activities while maintaining a disciplined and nurturing environment for both students and staff. The Vice...
-
Principal Engineer
2 weeks ago
Delhi, India Air Liquide Full timeJob Description How will you CONTRIBUTE and GROW Job Description Summary The Principal Engineer is part of the hierarchical organization, reporting directly to Team Manager as direct discipline superior. Senior Principal Engineer is having strong ability in technical matters with profound knowledge of applicable Engineering principles and processes with...
-
Principal Biostatistician
1 week ago
India Cytel, India Full timeCytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where...
-
Principal BIM Modeller
6 days ago
Bengaluru, India WSP Full timeJob Description We are seeking a highly skilled and experienced Principal BIM Modeller to join our civil engineering team as part of our bridge design and construction projects. As a Principal BIM modeller, you will play a crucial role in creating detailed and accurate Open Building Designer drawings and models for bridge structures. You will work closely...
-
Principal Biostatistician
1 day ago
India Cytel, India Full timeAt Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development. A **Principal Biostatistician** with a passion for clinical development...
-
SAP Security Control Principal
3 days ago
india LyondellBasell Full timeBasic FunctionSAP Security & Control Principal is the technology leader responsible for LYB’s SAP security and control applications, processes and procedures and best practices. He/ she brings the breadth and depth of SAP specific security & control automation expertise to LYB’s business transformation.He/ she will provide technology leadership to all...
-
Principal Biostatistician
2 weeks ago
India Cytel, India Full timeCytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where...
-
Principal Engineer
5 days ago
Hyderabad, India Zf Friedrich Full timeJob Description Job Description : Long Description Your Tasks: - As a senior IT Analyst / Developer focused on Environmental, Health, and Safety (EHS) and Sustainability, you'll play a crucial role in ensuring the smooth operation of ZF's local and global EHS systems. Your responsibilities will span various areas, combining technical expertise with...
-
Bengaluru, India GE Vernova Full timeJob Description Job Description Summary As part of GE Vernova Wind Engineering, the Blade subsystem team has responsibility for the design and support of wind blade components and systems. As the Principal Engineer - Blade Validation, you are responsible for the overall technical underwriting and acceptance of blade structural design validation. You will...
-
Principal Engineer
2 weeks ago
Bengaluru, India WSP Full timeJob Description As the Principal Engineer - Electrical, you will play a crucial role in leading electrical engineering projects from conception through execution. You will leverage your expertise to drive design, development, and implementation of complex electrical systems while ensuring alignment with industry standards and safety regulations. The ideal...
-
Principal Statistical Programmer
7 days ago
Bengaluru, India ICON plc Full timeJob Description Principal Statistical Programmer - India - Office or Home ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking...
-
Senior Principal Process Engineer
2 weeks ago
Chennai, India McDermott International, Ltd Full timeJob Description Job Description Job Overview: The Senior Principal Process Engineer is tasked with solving unique and complex problems that have a broad impact on the business. They must proactively identify and solve the most complex problems that impact the management and direction of the business. The Senior Principal Process Engineer is considered a...
-
Technical Principal
4 days ago
Mumbai, India Mott MacDonald Full timeJob Description Job Description This is an excellent role in which you will lead a multidisciplinary design team within GDS (Global Delivery Services) to deliver various projects such as water and wastewater treatment works (non-infrastructure) design and pipeline (infrastructure) design for UK water utility companies. You will be - working closely with...
