Global Periodic Reporting Lead
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Job title: Global Periodic Reporting lead
Location: Cambridge, MA / Morristown, NJ / Swiftwater, PA
About the Job
Join the engine of Sanofi’s mission, where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
As 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?
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
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 You
Experience:
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.
Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
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, and additional benefits information can be found here.
Job details
How this role compares
Computed from every other active Pharmacovigilance role in our database, not just this employer's listings.
We currently track 113 comparable Pharmacovigilance roles across 43 biopharma companies.
Salary context
35 of 113 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 113 comparable roles
+ 17 more countries
Seniority mix
79 of 113 peers have a known seniority level
Therapeutic area mix
14 of 113 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.