Sr. Manager - Contract - Boston - REMOTE
Help bring science to life and join a leading pharmaceutical company to play a key role in delivering impactful research that drives healthcare innovation!
Proclinical is seeking a Sr. Manager, ASR to join a dynamic team in the oncology and pharmaceutical space.
Primary Responsibilities:
The successful candidate will focus on driving the development, planning, and management of aggregate safety reports, ensuring compliance and high-quality deliverables. This is a remote opportunity based out of Boston.
Skills & Requirements:
- Strong project management skills with the ability to lead complex initiatives.
- Excellent strategic decision-making and analytical abilities.
- Experience with compliance inspections related to pharmacovigilance (PV) and Good Clinical Practice (GCP).
- Familiarity with working alongside alliance partners.
- Medical writing experience, particularly with regulatory documentation.
- A bachelor's degree in Life Sciences or a related field is preferred.
- Background in pharmacovigilance with a focus on authoring and managing aggregate safety reports.
The Sr. Manager's responsibilities will be:
- Lead the development, production, and distribution of aggregate safety reports, including PSURs/PBRERs, PAERs, DSURs, and SUSARs.
- Provide expertise and guidance to authors and contributors involved in aggregate report creation.
- Maintain compliance metrics and contribute to corrective and preventive actions (CAPA) for non-compliance issues.
- Implement and manage effective structures, procedures, and tools to ensure timely and high-quality completion of aggregate reports.
- Oversee functional specifications for data requirements from safety and clinical databases.
- Collaborate with cross-functional teams, including Global Patient Safety (GPS), Epidemiology, Clinical Development, Regulatory Affairs, and Statistics, to support aggregate safety reporting activities.
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at b.forsen@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy
