Job Description
Our client, A leading Medical Technological Company is seeking a Remote Drug Safety Scientist to join their team.
Job Title: Drug Safety Scientist Location: Remote (EST Time zone) Pay Range: $40-50/HR on W2 Must haves: - Bachelors/Masters degree in Science(Pharmacy, Bio Technology or Chemistry)
- Experience in pharmacovigilance is a must (5 + years).
:
- The Drug Safety (DS) Scientist works within Drug Safety & Risk Management group.
- S/he performs pharmacovigilance tasks and prepares submission-ready regulatory documents within agreed time frames and to a high standard of accuracy, in compliance with our client's business rules, standard operating procedures and global and local regulatory requirements.
- The Drug Safety (DS) Scientist will provide scientific support to Drug Safety physicians for safety scientific activities from clinical trials and post-marketing experience.
Primary responsibilities
- Author aggregate safety reports required by health authorities such as, Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), US Periodic Adverse Drug Experience Report (PADER).
- Produce high quality, accurate and fit-for-purpose evaluation documents with clear conclusion, in response to internal or regulatory authority safety-related requests.
- Run accurate queries and provide standard outputs of the data from the safety database; create draft reports/data tables and to perform searches of the safety database for ad-hoc queries.
- Support preparation of RMP and post-marketing safety monitoring activities.
- Review publications from worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports.
- Conduct routine and ad-hoc signal detection and evaluate safety data and signals as part of ongoing pharmacovigilance activities. This includes the ability to summarize data from multiple sources and authoring signal evaluation reports.
- Provide support to the compilation of information for reference safety information (including Company Core Safety Information).
- Participate and contribute to Safety Management Team meetings.
- Support Drug safety physicians in handling issues related to both clinical and post-marketing safety, as needed.
- Perform other duties related to the position as necessary and as defined in SOPs and/or at the request of supervisor.
Requirements:
- Minimum of 3 years of pharmaceutical/biotechnology PV experience, including clinical trial and post-marketing experience
- Bachelor or Master of Science(required)
- Experience in authoring of aggregate safety reports.
- Strong knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance.
- Experience with coding according to the Medical Dictionary for Regulatory Activities (MedDRA).
- Ability to function in an environment of rapidly changing priorities and to manage multiple projects simultaneously while maintaining a high level of quality, accuracy and attention to detail.
- Excellent oral and written communication skills.
- Excellent computer skills, including Microsoft Word, PowerPoint and Excel.
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands -
Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
Job Tags
Full time, Local area, Worldwide,