Pharmacovigilance Document Specialist

Company Description

Established in 2000, A Minority Business Enterprise (MBE), LanceSoft Inc. is a pioneer in providing premium end-to-end Professional IT/Non-IT Contingent Workforce Solutions and IT Services to diverse clients across various domains.
Core Service Offerings
We offer a gamut of services across diverse domains, categories, skill sets with varying lengths of assignments, that include, but are not just limited to:
- Temporary Staffing
- Permanent Staffing
- Payrolling
- Recruitment Process Outsourcing (RPO)
- Back-office Services
- Application Design and Development
- Website Design and Development
- Program/Project Management
Our Domain Strength
With currently over 1000+ staff serving over 49 clients worldwide including “Fortune” companies, LanceSoft serves a wide array of industries including Healthcare/Pharma, Clinical/Medical Devices, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking, Finance, Insurance, Manufacturing, Automobile, Media, Transportation, and Government Sectors.
Geographic Coverage
LanceSoft is headquartered in Herndon, Virginia and has a network of branch offices across the US in Chicago (IL), Irving (TX), Basking Ridge (NJ), Atlanta (GA) and San Diego (CA). We also have an International footprint with two country offices in Canada (ON and BC) along with three delivery centers in India- Bangalore, Indore and Hyderabad to further help serve our clients better. We currently operate and recruit in 49 US states catering to diverse Contingent Workforce needs of our clients.
Awards and Accolades
Following are some of our awards and accolades in the US Contingent Workforce space:
- Manpower “Premier Vendor” – 2014
- Kelly’s “Supplier Innovation Award” – 2012
- Kelly’s “Supplier of the Year” Award – 2012 and 2011
- Kelly’s “Service Excellence Award” – 2010 and 2009
- “Stewardship Recognition” from Johnson & Johnson’s (J&J) Kelly Work sense program

Specialties

IT/Non-IT Contingent Workforce Services, Creative Solutions, Temporary/Permanent Staffing, Recruitment Process Outsourcing, Payrolling, Application Design and Development, Back-office Services, Program/Project Management, Website Design and Development

Job Description

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.

Qualifications

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.

Additional Information

Thanks and Regards
Dishant Nagar

Summary

• Type: Contract
• Function: Quality Assurance
• Experience level: Mid-Senior Level
• Industry: Pharmaceuticals