Job Description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

Pharmacovigilance Specialist I

Reference Code US-PAE945-90194

About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap ® and CAPS ® .
Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise ® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit .

Duties and responsibilities

• Position Summary:
• Responsibilities: Essential Duties
• Receive and process incoming adverse events reports for B.Braun pharmaceutical products.
• Monitor and evaluate complaints for potential Adverse Drug Experiences (ADEs) / Adverse Drug Reactions (ADRs) and initiate Medical Assessment (MA) of the events including coding using medDRA - Medical Dictionary for Regulatory Activities classification.
• Monitor Health Canada (HC) online Adverse Reaction Database for Serious reported events.
• Manage and file Product Incident Reports.
• Process and evaluate Expedited and Non-expedited ADE reports to the FDA, review for completeness and accuracy.
• Process and evaluate expedited CIOMS reports to Health Canada (HC), review for completeness and accuracy.
• Provide adverse event information for inclusion in aggregated reports including Periodic Adverse Drug Experience Reports (PADER) and Periodic Benefit-Risk Evaluation Reports (PBRERs), Signal Detection Reports as well as other reports requiring adverse event information.
• Ability to work non-standard schedule as needed G eneral:It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
• The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Manager from time to time.
• Expertise: Knowledge & Skills
• Requires basic knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
• Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of other peers.
• Some degree of judgment required in resolving problems based on experience.
• Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.
• #ID
• #LI
• #EL

Professional competencies

• Expertise: Qualifications -Education/Experience/Training/Etc
• Required:
• Associate's or technical degree required, Bachelor's degree preferred.
• 0-02 years related experience required.
• industry/professional certification preferred.
• While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

What we offer

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Job Tags

Similar Jobs