Proclinical is currently recruiting for a PV Scientist for an international pharmaceutical company located in Princeton, NJ. Successful candidate will be responsible for the overall the safety of the company's compounds. Candidate will be working collaboratively within the Global Clinical Development organization.
- Be the Safety expert for products the Company is developing or marketed.
- Review and collect ICSR documentation along with aggregate report (DSUR/PSUR) review.
- Comfortably interact with and expertly navigate ArisG safety database as it pertains to aggregate report submission, ICSR evaluation, and other pharmacovigilance tasks.
- Maintain pharmacovigilance expertise, and understanding of international safety regulations and guidelines.
- Provide strategic and proactive safety input into development plans.
- Oversee global clinical assessment of adverse events and safety signals collected from clinical trials, and post market surveillance in the therapeutic areas of oncology, CNS, DM and CV diseases.
- Provide proactive risk assessment, and develop risk management strategies.
- Represent safety position in cross functional submission teams. Ensure generation, consistency, and quality of safety sections in submission documents. Author responses to health authorities' questions and support preparation of Advisory Committee meetings.
- Responsible for signal detection and evaluation. Identify and implement proactive safety analysis strategies to further define the safety profile.
- Lead aggregate safety data review activities and coordinate safety surveillance activities.
- Support due diligence activities and pharmacovigilance agreements.
Skills and Requirements:
- Clinical degree in either Pharmacy, Nursing, or a life science related field.
- Minimum 3 years of clinical research experience.
- Able to develop and document sound risk assessment.
- Able to work collaborative within the Global Clinical Development organization.
- Demonstrates leadership within cross-functional team environment for safety related issues.
- Good communication skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.