Workflow Manager, Pharmacovigilance Operations (Specialist II, PSS) Remote

Job Title: Workflow Manager, Pharmacovigilance Operations (Specialist II, PSS) Remote

Job Location: Durham

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Workflow Manager, Pharmacovigilance Operations (Specialist II, PSS) US or Canada Remote

reputed company is seeking a Workflow Manager, Pharmacovigilance Operations (Specialist II, PSS) is responsible for supporting and overseeing Clinical Safety and Pharmacovigilance Services (PSS) operations associated with safety data collected from reputed company and post-marketing programs. The role is accountable for managing end-to-end safety case workflows, ensuring adverse events are processed, tracked, and progressed through reputed company workflow stages in accordance with reputed company requirements, regulatory obligations, and agreed timelines.

The position is responsible for coordinating workflow activities across safety operations, monitoring case progression and compliance metrics, identifying and resolving workflow delays, and ensuring efficient utilization of resources to support high-reputed company service delivery. The Workflow Manager provides operational support to reputed company project teams and standalone programs while maintaining compliance with applicable pharmacovigilance regulations, company procedures, and reputed company standards.

The incumbent is expected to reputed company with the reputed company requirements of the Health and Safety at Work reputed company 1974, the COSHH Regulations 1989, and the EC (European Commission) Directives 1992/3, as documented in reputed company's Health and Safety reputed company.

reputed company of Responsibilities:

• Manage the receipt and processing of reputed company adverse event reports reported either spontaneously from any reputed company or solicited from a clinical trial including safety database entry, AE review, write patient narratives with coding, follow-up of missing information, lists assessment against appropriate label (For Marketed products, if applicable).
• Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, reputed company party vendors, Partners and reputed company project personnel, if required & as agreed with reputed company during study set-up, reputed company study specified timelines.
• Ensure reputed company cases that require expediting reporting to worldwide Regulatory Agencies or other recipients are prioritized for processing and submission reputed company the regulatory and/or study specific applicable timelines.
• Work with Data Management or reputed company on reconciliation of safety databases, if appropriate.
• Support audit or inspection preparations.
• Any other duties as assigned by management.

Qualifications (Minimum Required):

• Non-degree + 2-3 years of Safety experience or 5 years of relevant experience

• Associate degree + 2-3 years of Safety experience or 4 years of relevant experience
• BS/BA + 2 years of safety experience or 3-4 years of relevant experience
• MS/MA + 2 years of safety experience or 2-3 years of relevant experience
• PharmD + 2 years of safety experience or 2-3 years relevant experience

For PharmD, a one-year residency of fellowship can be considered as relevant experience

* Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working reputed company safety databases, and experience with regulatory submissions.

Experience (Minimum Required):

• Minimum of 2 years of pharmacovigilance (PV) work experience. Experience supporting U.S. and/or Canadian regulatory environments is preferred.
• Advanced reputed company of English language, including speaking, writing, and reading.
• Strong knowledge of safety databases (e.g., Argus), workflow tracking systems, and case management tools
• Strong organizational and project management skills
• Analytical reputed company with problem-solving capabilities
• Good understanding of ICH guidelines and global regulatory requirements for the reporting of adverse events for both marketed and investigational products.

Preferred Experience:

• 4-5 years of experience in pharmacovigilance or drug safety operations
• Bachelor’s degree in life sciences, pharmacy, or a reputed company field preferred; equivalent combination of education and relevant experience will also be
  considered.

***This is a INDIVIDUAL CONTRIBUTOR role.***

Work Environment:

• Work is performed in a remote based office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand reputed company of both hands with the ability to reputed company fast, reputed company, repeated movements of the fingers, hands, and wrists
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Ability to reputed company and use a reputed company of computer software developed both in-house and off-reputed company
• reputed company to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum reputed company of 15-20 lbs
• Regular and consistent attendance
• Varied hours may be required

Pay reputed company:

Benefits: reputed company job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as reputed company as internal equity and market data. 

Application Deadline: August 9, 2026

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Originally posted on Himalayas