Job title: Global Periodic Reporting lead
Location: Cambridge, MA / Morristown, NJ / Swiftwater, PA
About the JobAs Global Periodic Reporting Lead within our Pharmacovigilance team, you will ensure and develop robust , compliant, and controlled processes for Periodic Safety Report (PSR) authoring and vendor oversight. You will lead the Periodic Report Expert (PRE) Team through coaching and mentorship while managing the annual worldwide regulatory planning of PSRs for the entire company portfolio. You will develop and execute outsourcing strategies, uphold regulatory compliance, and drive process improvements to leverage efficiencies. Ready to get started?
Main Responsibilities:- Ensure and develop robust , compliant, and controlled processes for Periodic Safety Report (PSR) authoring and vendor oversight while upholding regulatory compliance expectation
- Lead the Periodic Report Expert (PRE) Team through coaching, mentorship, and development planning according to individual and organizational priorities
- Develop and execute outsourcing strategies for PSR authoring according to business criticality and resourcing needs
- Establish and maintain the annual worldwide regulatory planning of PSRs for the entire company portfolio (clinical and postmarketing)
- Manage PSR Planning Team with regard to PSR planning activities, resource allocation, and training needs
- Serve as system owner for the PSUR Web page Repository and tracking tool database
- Identify, implement, and support process improvements to leverage efficiencies and drive continuous improvement
About YouExperience:- Experience in international pharmacovigilance for marketed drugs and/or projects under clinical development
- Proven track record in transversal collaboration
- Experience compiling and drafting PSRs and safety reports
Technical and Soft Skills:- Excellent technical, clinical and critical analytical skills with keen understanding of clinical safety processes and analysis
- Strong understanding of global regulatory framework governing PSRs and worldwide pre and post marketing safety reporting regulations and ICH guidelines
- Leadership skills including team motivation, problem-solving, initiative-taking, and strong negotiation skills
- Process improvement experience (LEAN, Continuous Improvement) and project management of multifactorial activities with successful prioritization
- Excellent written and oral communication skills and computer literacy
Education:- Bachelor's degree in health science or related field
Languages:- Fluent English (written and spoken)
Why Choose Us? - Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
The salary range for this position is:
$178,500.00 - $257,833.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
