12 ago
|
Syneos Health
|
Tlalnepantla de Baz
12 ago
Syneos Health
Tlalnepantla de Baz
OverviewSafety Specialist II - HYBRID - ARG
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. Our Clinical Development model brings the customer and the patient to the center of everything that we do. 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.
Work Here Matters Everywhere
What we offer
- Career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- Committed to a Total Self culture – authentic environments where you can be yourself and care for our people.
- Diversity of thoughts, backgrounds, cultures,
and perspectives to foster belonging.
Job Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
- Assist in the preparation of project plans such as Safety Management Plan.
- Set-up, delivery and close-out of safety and pharmacovigilance projects.
- Process ICSRs according to SOPs and project/program-specific safety plans.
- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.
- Enter data into safety database. Code events, medical history, concomitant medications, and tests.
- Compile complete narrative summaries and assess information to be queried, following up until information is obtained and queries are resolved.
- Contribute to timely, consistent, and accurate reporting of expedited reports in accordance with regulatory requirements.
- Coordinate with data management regarding reconciliation of
📌 Safety Specialist II (Tlalnepantla de Baz)
🏢 Syneos Health
📍 Tlalnepantla de Baz