Manager, Global Drug Safety & Pharmacovigilance

$120k - $130k

Full-time

Asahi Kasei America, Inc.

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.
Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.
Company:
Veloxis Pharmaceuticals, Inc.
Job Description:
This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence. The incumbent in this position also serves as a safety liaison with the Company's cross-functional teams, license partners and the contract safety organizations responsible for global drug safety and pharmacovigilance.
The base compensation range for this role is $120-130K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.
Summary of Key Responsibilities
Serve as resource and contact for other functions within the company for pharmacovigilance operational activities
Responsible for overall vendor performance and vendor service outputs (delivered timely and on budget) including, but not limited to:
Oversight of US AE call center;
Oversight of adverse event processing by outsourced vendor, including the review and monitoring of compliance through various monitoring reports / KPIs;
Participation in quality audits of individual case safety reports (ICSR) following vendor processing, with a specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, expectedness against RSIs and appropriateness of queries to seek follow-up from the clinical sites / reporter;
Oversight of adverse event reconciliation between safety and clinical databases, and adverse events exchanged between licensing partners;
Review of safety-related section of aggregate reports (DSUR, PSUR/PBRER, PADER, RMP);
Review and approval of pharmacovigilance related documents submitted to the Trial Master File (TMF);
Provision of vendor project specific training;
Collaboration with vendors to develop Safety Management Plans (SMP) and relevant forms and templates;
Collaboration with vendors to develop process-related documents for the purposes of improvement and standardization of new processes; and
Maintaining knowledge of safety systems (Argus experience preferred);
Assist in creating and maintaining standard operating procedures and working practices to ensure inspection readiness and compliance with regulations and guidelines;
Support internal / external audits and regulatory inspections;
Assist in management of pharmacovigilance vendor contracts and forecasting activities;
Assist in management of license partner safety data exchange agreements (SDEA);
Assist management in establishing and coordinating all product safety operations functions in accordance with regulations and the Company's policies and procedures;
Assist in preparation and review of regulatory submissions, such as safety reports and aggregate / periodic reports;
Represent the Company in product safety meetings with its cross-functional teams, license partners and contract safety organization;
Provide training to Company personnel and third parties for pharmacovigilance requirements and compliance;
Maintain current knowledge of regulations and regulatory guidelines, particularly in the US, Europe and Japan.
Required Qualifications and Skills
Bachelor's degree in life sciences, nursing, pharmacy, or related healthcare profession with relevant experience
At least 5 years of pharmaceutical industry drug safety and pharmacovigilance experience involving development and post-marketed products
Solid vendor management or CRO pharmacovigilance project management experience, including safety management plan preparation, establishment of KPIs / metrics, and contract management
Strong knowledge of ICSR processing and the adverse event lifecycle
Solid experience with drug safety databases, especially with Argus; data migration experience preferred
Ability to independently identify, analyze, and solve complex operational and data-related issues
Strong understanding of current pharmacovigilance practices and global pharmacovigilance regulations, including regulatory reporting requirements
Self-motivated, detail-oriented, with the ability to prioritize and plan effectively
Excellent written and verbal communication skills
Ability to work both independently and within a matrixed team in a dynamic, fast-paced environment with shifting priorities
Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro
Travel Requirements: Approximately 10%
#LI-AS1 #Hybrid
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

Apply

Vacancy posted 5 days ago

Similar jobs that could be interesting for youBased on the Manager, Global Drug Safety & Pharmacovigilance in Cary, NC vacancy

Global Quality Manager
...manufacturer of extrusion base and silicone-coated release liners for the converting industry. We have an exciting opportunity for a Global Quality Manager to join our team. Reporting to the Senior Director of Global Quality, this role provides tactical leadership for...
Suggested
Loparex LLC
Cary, NC
2 days ago
Business Relationship Manager
$126.7k - $171.4k
...10+ years’ experience with 1-2 plus years in sales roles Strong record of growing IT services in global pharma accounts Local candidates/customer proximity At least managed 5+ MN annual revenue Roles & Responsibilities Lead large scale client business development, delivery...
Suggested
Local area
Tata Consultancy Services
Morrisville, NC
1 day ago
Executive Director, Project Management
...Executive Director, Project Management About the Company International contract... ...cell and gene therapy global & local regulatory support phase... ...equity diversity and inclusion drug safety & pharmacovigilance bioanalytical lab clinical pharmacology...
Suggested
Contract work
Local area
Confidential
Raleigh, NC
5 days ago
Head of Global Talent Acquisition
...Lead, develop, and continue to strengthen a high-performing global talent acquisition team of approximately 20, with four direct reports... ...a metrics-driven operating model. Run a disciplined account-management model in partnership with senior business leaders and the Heads...
Suggested
Jobtailor
Raleigh, NC
10 hours ago
Clinical Trial Manager - Full Service
...Clinical Trial Manager - Full Service Syneos Health... ...culture is what unites us globally, and we are dedicated... ...a focus on patient safety, protocol/GCP/regulatory... ..., medical monitoring, pharmacovigilance and Quality Assurance... ...all Novel FDA Approved Drugs, 95% of EMA Authorized...
Suggested
Flexible hours
Syneos Health/ inVentiv Health Commercial LLC
Morrisville, NC
4 days ago
Senior Manager
...Managed Cloud Services Offering Manager, Hyperscaler Hybrid SAS Managed Cloud Services (MCS) provides hosting services for SAS products... ...solutions and related third party technologies, while enabling global consistency through communities of practice, standardized...
Full time
Local area
SAS
Cary, NC
5 days ago
Principal Specialist, Global Strategic Sourcing Work Transfer Project Manager (remote)
$82k - $164k
Principal Specialist, Global Strategic Sourcing Work Transfer Project Manager (remote) Location: HNC99: Field Office - NC Remote Location, Remote City, NC, 27601 USA Date Posted: 2025-10-31 Country: United States of America Position Role Type: Remote U.S. Citizenship...
Remote job
Full time
Contract work
Temporary work
Work experience placement
Work at office
Work from home
Flexible hours
Collins Aerospace
Raleigh, NC
4 days ago
Automotive General Manager
$300k - $350k
...Holman is a family-owned, global automotive services organization anchored by our deeply rooted core values and principles that have... ...all around. The automotive markets Holman serves include fleet management and leasing; vehicle fabrication and upfitting; component manufacturing...
Full time
Temporary work
Part time
Work experience placement
Local area
Flexible hours
Holman Inc
Cary, NC
1 day ago
Residential Sales Manager
...Residential Sales Manager CertaPro Painters is a leader in the residential and commercial painting industry throughout North America. Our success is built on delivering certainty to our customers through exceptional service, professionalism, communication, and results...
Full time
Local area
Monday to Friday
Flexible hours
Weekend work
Afternoon shift
CertaPro Painters® of Cary-Apex, NC
Cary, NC
1 day ago
Youth Development Specialist
Milton Hershey School, a cost-free pre-K through 12th grade residential school, is seeking a Youth Development Specialist in the Education, Training & E-Learning department. This role supports students’ academic, social, and emotional growth through mentoring, small-group...
Milton Hershey School
Cary, NC
4 days ago
Marketing Director
...redefining what’s possible. We create for our global customers engineered components and sub-... ...market and customer research. Create and manage demand generation budgets and forecasts.... ...compliance with quality, occupational safety, and environmental regulations. Implementation...
Novanta
Apex, NC
1 day ago
Global Sales Account Executive
...grown every year since, and today we're proud to be a $16 billion global provider of IT solutions and services. Over 17,000... ...Partner and Industry Networking In collaboration with Sales Management, identify, create, develop and manage opportunities in the Sales...
Full time
Work experience placement
Work at office
Local area
Remote work
Worldwide
Home office
Flexible hours
SHI GmbH
Raleigh, NC
4 days ago
Learning and Development Manager
...Morrisville, NC hosts a Senior Talent & OD Specialist role within the Global Organization Development Team of WW Human Resources. The... ...schedule, and involves global collaboration. You will support talent management, org design, and change initiatives across multiple regions,...
Full time
Work at office
Lenovo
Morrisville, NC
4 days ago
Lab Manager
$120k
...Job Description Job Description Job Title: Lab Manager Job Description The Lab Manager will oversee a team of approximately 27... ...anticipated to close on Sep 16, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent...
Permanent employment
Interim role
Monday to Friday
Shift work
Day shift
Actalent
Cary, NC
14 days ago
Consumer Sales Manager
...growing fast paced eCommerce sales team. The Consumer Sales Manager (CSM) position will be responsible for generating revenue while... ...0 * Top 100 Internship Programs Winner, 2020 * Global 100 Most Sustainable Corporations by Corporate Knights, 2020...
Internship
Local area
Remote work
Home office
Flexible hours
Shift work
Weekend work
Lenovo
Morrisville, NC
4 days ago
Study Manager - Future roles (US)
Description Study Manager - Future roles (US) Syneos Health® is a leading fully integrated... ...Our Total Self culture is what unites us globally, and we are dedicated to taking care of... ...worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over...
Contract work
Immediate start
Flexible hours
Syneos Health
Morrisville, NC
4 days ago
InfoSec GRC - Senior Manager
..., or supporting in all operational aspects, including document management and systems and procedures analysis. The work model for the... ...Security & Compliance dashboard aggregating risk metrics from global and local security services, govern risk assessments, and ensure...
Full time
Temporary work
Local area
Monday to Friday
ABB
Cary, NC
7 days ago
Youth Development Specialist - Relocation to Hershey, PA Required
$46.92k
...development so they can reach their full potential. Responsibilities include: Providing daily supervision and mentorship Managing household routines and student schedules Administering medications and ensuring student wellness Driving students to...
Full time
Work from home
Relocation
Relocation package
Flexible hours
Weekday work
Milton Hershey School
Cary, NC
1 day ago
Sales Director
$50k - $250k
...services and support to deliver fully integrated trading and business management solutions to companies in the distributive trade - wherever... ..., sell profitably and service competitively. Klipboard is a global, growing business that embraces AI and emerging technologies to...
Work at office
Remote work
Work from home
Flexible hours
Kerridge Commercial Systems
Cary, NC
4 days ago
Marketing Program Manager
...CTG is seeking to fill a Marketing Program Manager position for our client. Location: Morrisville, NC- HYBRID with 3 days in the... ...Experience managing complex cross-functional marketing programs and global teams. Experience with portfolio management, resource...
Work at office
Local area
CTG, Inc.
Morrisville, NC
2 days ago
Senior Construction Manager
$88.8k - $133.2k
...Arcadis is seeking Senior Construction Manager to join our Arcadis Construction Services... ...flexible. This role sits within the larger Global Resilience Business Area. We work to... ...vendors, and client. Monitor health and safety, including daily briefings; conduct weekly...
Full time
Contract work
Part time
For subcontractor
Local area
Flexible hours
Arcadis
Cary, NC
4 days ago
Project Manager
...for an experienced A/E design side Project Manager to join our team. The Project Manager... ...the Arcadis Group of Companies and is a global EPCM firm offering full‑service solutions... ...Design, Construction Management, Health and Safety Management, Commissioning, Qualification,...
Work at office
Local area
Flexible hours
DPS Group Global
Cary, NC
6 days ago
Contracts Manager
$80k - $100k
...Tucson, AZ; Carmel, IN Purpose The Contract Manager negotiates contract terms that support... ...purpose and the impact we deliver. As a global provider of intelligent diagnostic informatics... ...with minimal exposure to health or safety hazards. Prolonged periods of sitting at...
Full time
Contract work
Work at office
Clinisys
Morrisville, NC
2 days ago
Director of Quality
$150.43k - $180k
...of Quality plans, directs and manages the Quality discipline across... ...metrics. ~ Lead monthly global Quality meetings. ~ Provide... ...for facility compliance with drug enforcement administration (DEA... ...ingredients essential to the safety, health, and wellbeing of our...
Work experience placement
Local area
Univar Solutions Univar Solutions
Morrisville, NC
21 days ago
Construction Project Manager (Civil)
$85k - $110k
...Description Job Description Project Manager | Heavy Civil ConstructionAbout the Opportunity... ...overall project execution while ensuring safety, quality, and client satisfaction remain... ...2026. About Actalent Actalent is a global leader in engineering and sciences...
Permanent employment
Contract work
For subcontractor
Work at office
Local area
Actalent
Cary, NC
2 days ago
Project Manager
...assistance. Implementing software that saves lives. Join our Project Management team and drive impactful projects to improve patient care in... ...stake in the success of Epic and our customers. Healthcare is global, and building the best ideas from around the world into Epic...
Work at office
Relocation
Visa sponsorship
Relocation package
Epic
Cary, NC
4 days ago
EPCM Project Director
$158.5k - $208.13k
...architectural design, procurement, construction management, and design‑build project delivery. We... ...impacts on the future - big and small, global and local. Required Qualifications... ...other PMs and Project Engineers Strong safety culture both from design safety, and...
Full time
Contract work
Temporary work
For contractors
Work at office
Local area
Jacobs
Cary, NC
5 days ago
Project Manager III
...’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every... ...helping find cures for cancer. DESCRIPTION As a Project Manager III at Thermo Fisher Scientific, you will lead complex, cross-functional...
Full time
Morrisville, NC
22 days ago
Project Manager
...inception of our staffing solutions has grown multi-fold with global offices. We know what works best for our clients and what doesn... ...better solutions . Enhance operational efficiencies Overall SLA management - Operation interaction with technologies Lead / Service Owner...
Permanent employment
Temporary work
Ktek Resourcing LLC
Cary, NC
5 days ago
General Manager
...become a critical partner in the global aviation industry, delivering... ...is our people. Role Purpose Safety, Security, and Environmental stewardship... ...falls to the General Manager. The MA General Manager is... ...through the misuse of alcohol and drugs. As such the Company prohibits...
Local area
Flexible hours
Night shift
Menzies
Morrisville, NC
6 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Manager, Global Drug Safety & Pharmacovigilance. Be the first to apply!