Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops new medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women’s health, urology, cardiovascular, respiratory and anti-infective therapeutic categories. The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications.

Actavis currently markets approximately 1000 generic, branded generic, established brands and Over-the-Counter (OTC) pharmaceutical products globally through operations in more than 60 countries. The company has global headquarters in Dublin, Ireland and U.S. Administrative Headquarters in Parsippany, New Jersey.

The Sr. Scientist in the PVRM Safety Information Management group is responsible for creating internal safety surveillance documents as well as safety reports for regulatory authorities for the company products, handling internal ad hoc queries/reports, analyzing/summarizing complex safety data, managing the operations of Safety Management Team (SaMT) meetings, managing signal detection activities, and preparing expedited safety report and investigator notification.

Primary responsibilities to include:

1. Prepare, compile, author various aggregate reports such as the annual and quarterly periodic ADE reports (PADER), annual IND reports, periodic safety update reports (PSUR), development safety update reports (DSUR), or the safety section of ISS (Integrated Safety Summary).
2. Compile ad hoc queries/reports from Business Objects (BOXI) and the drug safety database.
3. Initiate signal detection analysis and manage signal detection activities.
4. Finalize and distribute expedited safety report and investigator notification.
5. Produce and maintain monthly listings for insurance companies and ABPs including: Events of Interest and Manager Tracker.
6. Work with Informatics for safety surveillance tools/database implementation or upgrades. Perform testing in the development environment before rolling to production.
7. Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates.
8. Represent safety reporting to attend meetings with functional project team, business partners, and CROs.
9. Author responses to regulatory agency safety inquiries, and health hazard evaluation letters for company products.
10. Author SaMT supporting documents including Safety Specifications, Safety Surveillance Plans, and Justification Documents for label changes.
11. Collaborate with product safety physicians to summarize highly complex safety data from clinical studies and post-marketing experience for presentation at internal, external and professional meetings.
12. Manage safety labelling update and archival processes and associated tools including product Expectedness Guides.
13. Perform periodic scientific literature review for safety concerns.
14. Prepare/update internal training documents.
15. Develop/update templates for aggregate periodic safety reports that are consistent with FDA, EU, and ICH guidelines.

Position Requirements

Education:

Bachelor degree required; concetration in biomedical science or healthcare (pharmacy or nursing) with advanced degree in technical writing a plus.

Experience:

With minimum 5 years drug safety experience, experience in all safety regulatory document types (e.g., IND annual report, ASR, DSUR, PSUR, PADER, EU RMP, ISS, and ad hoc safety responses for Regulatory Authorities) or demonstrated experience in project management is a plus.

Licensure/Credentials:
None

Knowledge, Skills, and Abilities -
Understanding/knowledge of the following areas:
* FDA, EU, and ICH guidelines and regulations
* Pharmacovigilance and Risk Management
* Safety database management and design
* Clinical trials, and drug development
* Coding dictionaries (e.g., WHO ATC drug dictionary, and MedDRA)
Drug safety database knowledge is required: ARISg experience and navigation skills preferred
Proficiency with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat Professional
Familiarity with Microsoft Visio and Microsoft Project is a plus
Ability to work with templates
Experience with Business Objects (BOXI) is a plus
Must possess excellent skill/ability in the following:
* Oral and written communication
* Planning, coordination, and organizing
* Decision making, judgment, and problem Solving
* People relationships, team building, motivating employees, and influencing Others
* Initiative and accountability
* Promoting innovation and process Improvement
* Excellent attention to detail combined with the ability to summarize and present complex information clearly (in verbal and written form)
* Strong writing and presenting skills
* Good team player
* Ability to work in tight timelines while maintaining accuracy
* Ability to work proactively with minimal supervision

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.