Single Sponsor Senior Safety and Pharmacovigilance Specialist - can be based in Italy, France, UK, P

Description

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. 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.

Why Syneos Health

1. 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.
2. 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.
3. 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

This Global Risk Management & Safety Surveillance Scientist collaborates with the Physicians and Scientists to characterize the evolving clinical and post-marketing safety profiles for our clients investigational drugs and/or products, based on analysis of aggregate data sets from internal or external sources and the medical literature. This entails drafting, reviewing, and refining portions of periodic aggregate safety reports (including DSURs, PADERs/PAERs).

The GRMSS Scientist performs the signal detection activities and review process for clinical data, including signal detection, evaluation, and verification; potential sources of data for signal detection include internally, external marketing partners, or contracted business entities. The GRMSS Scientist in this position documents signal detection activities and communicates appropriate summaries to internal stakeholders and external partners.

Qualifications

What we're looking for

1. Previous Safety/PVG experience gained from a Pharmaceutical company.
2. Experience analyzing safety case reports for the purposes of preparing aggregate safety reports (DSURs, PADERs), signal detection and evaluation, and responding to queries by regulatory authorities required.
3. Experience incorporating safety findings into aggregate reports (DSURs, PADERs/PAERs) required.
4. Experience in pharmacovigilance relating to oncologic or inflammatory diseases, or relating to clinical support of oncology, immunomodulatory, or other related products preferred.

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.