Drug Safety Scientist
Proclinical is currently recruiting for a Drug Safety Scientist for a global pharmaceutical company located in Bridgewater, NJ. Successful candidate must be an experienced and confident PV Safety Scientist who can provide functional and technical expertise while collaborating with multiple stakeholders.
- Serve as a product lead for PV activities within the GPV & RM, Aggregate Safety Reporting function for DSURs, PBRER/PSURs, Pharmacovigilance Plans, REMS, RMPs and Ad Hocks.
- Lead in aggregate report responses to safety questions from internal and external stakeholders, with GSL input and reviewing medical and scientific literature for safety information and supporting Clinical Trial PV medical activities such SMPs.
- Support the GSL Physician in the signal management process for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities.
- Serve as a SME for GPV and cross-functional teams on relevant global safety regulations and guidelines, data output and analyses, and product-specific information. Additionally, leads process for responding to safety questions from regulatory authorities.
- Manage literature review for safety information and supports ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature and assists the GSL Physician in determining the impact of newly identified safety issues on the product's benefit/risk profile.
- Provide support to GSL Physician in activities relating to monitoring and management of Product's emerging safety profile.
- Support the logistics of Safety Action Committee meetings, maintains roster, calendar, and minutes/communication.
- Collaborate with GSL for assigned investigational programs including clinical trial activities safety committee management, data analysis, signal detection, ad-hoc requests and other product activities, as assigned.
- Contribute to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
Skills and Requirements:
- Bachelors' in biologic or natural science; or health case discipline Advanced degree (e.g., R.N, PharmD,) or extensive PV Safety experience preferred.
- 4-6+ years of experience in the pharmaceutical/ biotechnology industry in pharmacovigilance safety related role.
- Ideally looking for a combination of experience including experience in aggregate safety reports and safety signal management. Strong background in clinical trial drug safety is required.
- Excellent understanding of PV regulatory environment with working knowledge of FDA, EMA and ICH regulations, Guidance, best practices, and GPV&RM.
- Understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format.
- Demonstrate leadership and interacts collaboratively and effectively in a team environment, as well as with external colleagues.
- Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to Health Authorities' requests. Oversees and mentors less experienced PV Safety Scientist staff.
- Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts.
- Strong organizational skills, including the ability to prioritize independently with minimal supervision.
- Basic knowledge of common data processing software.
- Knowledge of common safety database systems.
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 Yannick Dada (+1) 646-741-8433 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.