What are the responsibilities and job description for the R20089 Temp Specialist, PV Planning position at Regeneron?
R20089 Temp Specialist, PV Planning
Pay Range: Min 60 - Max 65
Responsible for supporting PV Planning in the successful conduct of safety related activities supporting primarily early stage clinical compounds in accordance with applicable GCPs and/or regulations.
- Exercises independent judgment in maintaining compliance with SOPs and applicable worldwide regulations to ensure timely and consistent GPS deliverables.
- Contributes to continuous improvement/quality system initiatives applicable to PV Planning deliverables. Supports development and maintenance of SOPS and Work Instructions.
- Assumes lead role and is liaison for internal and external personnel for safety-related issues, specific to SAE Management, generally supports Phase I & II programs.
- Works closely with Regulatory, Clinical Development, and Data Management personnel.
- Frequently interacts with GPS personnel during conduct of essential responsibilities.
- May participate in interdepartmental project teams for Phase I & II programs.
Education
Bachelor’s Degree in life sciences required (Pharmacy, Nursing or equivalent); advanced degree preferred.
Experience
- Two to three years of previous safety or clinical experience in the pharmaceutical industry required
- Working knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for either clinical trial or post-marketing environments required
This is a contract position at Regeneron with Magnit Global being the Employer.
To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
