Pharmacovigilance Document Specialist

Title: Document Control Specialist-III

Location: Horsham- PA

PV Controlled Documents is a member of the Training & Document Control Center of Excellence (TDC CoE) group within Compliance Strategy and Analytics and is responsible for development and delivery of Global Medical Organization (GMO), Office of Consumer Medical Safety (OCMS) and Dual-sector medical safety procedural documents.

The Senior Associate, PV Documents is responsible for assigned deliverables to promote regulatory compliance with respect to pharmacovigilance. This involves procedural document development on GMO, OCMS, and Dual-Sector Pharmacovigilance (PV) processes and pharmacovigilance-focused regulations.

The Senior Associate, PV Controlled Documents identifies and supports improvement activities for a document management department of the highest standards that may be leveraged to support other Client’s organizations and sectors as appropriate by actively interacting with Client colleagues.

The Senior Associate, PV Documents supports projects that ensures document development requirements are identified and aligned to overall strategic objectives.

The Senior Associate, PV Controlled Documents may participate on functional teams for projects in order to support achieving program deliverables.

Support the development and delivery of assigned procedural documents by actively partnering with GMO/OCMS functional areas, other partners and Medical Safety Organizations as needed to ensure that desired outcomes and deliverables are met.

Support procedural document initiatives and projects of moderate complexity.

Facilitates Cross-pharma Reviews and Impact Assessments as needed.

Provide Audits and Inspections support and litigation request support.

Facilitate Procedural Document Committee meetings.

Other duties as assigned.

The position requires the ability to

• Manage multiple, moderately complex procedural document assignments within timeframes with minimal guidance.
• Communicate, both verbal and written, and collaborate effectively and professionally with internal colleagues and external parties
• Lead committee meetings and projects/initiatives professionally
• Foster consensus and make decisions independently appropriate to subject matter and responsibilities
• Experience in procedural document development or quality role for a minimum of 5 years preferably in pharmaceutical industry
• Demonstrated experience in Electronic Document Management System(s)
• Proficient in Microsoft Word, PowerPoint, Excel, and Visio.
• Pharmacovigilance knowledge or experience preferred.
• Demonstrated strong Credo values.
• Excellent oral and written communication skills, including formal presentation skills.
• Commitment to providing excellent customer service.
• Ability to work independently and successfully manage multiple priorities simultaneously.
• Ability to establish successful working relationships with staff at all levels within the organization during the development of procedures.

Thanks and Regards

Dishant Nagar

703-480-4117