Description
Safety & PV Specialist I (case processing experience) Hybrid CDMX-MexicoSyneos 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.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
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
- Perform comprehensive medical review and clarification of trial-related Adverse Events, ensuring accurate documentation and timely reporting to regulatory authorities
- Provide detailed aggregate reviews of safety information, identifying potential safety signals and trends that may impact the clinical trial outcomes
- Serve as an internal consultant to pharmacovigilance case processing teams, offering expert guidance on complex safety issues and ensuring compliance with regulatory requirements
- Contribute to the detection of safety signals and trends through rigorous analysis of safety data, utilizing advanced methodologies and tools
- Conduct thorough risk management assessments, evaluating the potential risks associated with clinical trials and recommending appropriate mitigation strategies
- Provide proactive safety support to clinical development teams, collaborating closely to enhance the overall quality and safety of clinical trials
- Participate in all aspects of the medical safety team's involvement in assigned trials, including protocol development, safety monitoring, and reporting
- Ensure accurate and timely reporting of safety information, maintaining high standards of data integrity and compliance with regulatory guidelines
- Enhance the overall quality and safety of clinical trials by implementing best practices and continuous improvement initiatives
Qualifications
- Bachelor's degree in a relevant field (e.g., Pharmacy, Medicine, Life Sciences)
- Minimum of 1-2 years of experience in pharmacovigilance or related field
- Strong understanding of clinical trial processes and safety regulations
- Excellent analytical and problem-solving skills
- Effective communication and interpersonal skills
Certifications
- Certification in Pharmacovigilance or Drug Safety (preferred)
- Relevant professional certifications (e.g., PMP, Six Sigma) (optional)
Necessary Skills
- Proficiency in medical review and safety signal detection
- Ability to manage and interpret complex safety data
- Strong attention to detail and accuracy
- Ability to work independently and as part of a team
- Proficiency in using pharmacovigilance databases and software
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.
Summary
Roles within Pharmacovigilance & Safety job family at the P20 level are responsible for providing expertise on pharmacovigilance services. This includes participating in all aspects of the medical safety team's involvement in assigned trials, such as performing medical review and clarification of trial-related Adverse Events, providing aggregate reviews of safety information, and serving as an internal consultant to pharmacovigilance case processing teams. These roles also contribute to trends and safety signal detection, risk management assessment, and provide safety support to the clinical development teams.Impact and ContributionRoles within Pharmacovigilance & Safety job family at the P20 level have a significant impact on the safety and efficacy of clinical trials. By performing medical reviews and clarifications of trial-related Adverse Events, these roles ensure accurate and timely reporting of safety information. They contribute to the detection of safety signals and trends, which are crucial for risk management and assessment. Additionally, these roles provide valuable safety support to clinical development teams, enhancing the overall quality and safety of clinical trials.Core Focus•Performing medical review and clarification of trial-related Adverse Events•Providing aggregate reviews of safety information•Serving as an internal consultant to pharmacovigilance case processing teams•Contributing to trends and safety signal detection•Conducting risk management assessment•Providing safety support to clinical development teams
