Sunovion Principal Scientist, Pharmacovigilance and Risk Management in Fort Lee, New Jersey

Job Description:

The Principal Scientist reports to the Senior Drug Safety Physician as part of a team that performs high quality and timely scientific and operational analysis of pharmacovigilance information. This position works closely with the Safety Systems & Information Management and Strategic Alliance, Compliance & Training groups as part of a matrix team to support the Therapeutic Area business unit by ensuring that pre- and post-marketed products are adequately supported from a safety standpoint.

Job ID: 6558BR

Department: Research & Development

Location: Fort Lee, NJ

Job Type: Full-time

Summary of Responsibilities: The Principal Scientist reports to the Senior Drug Safety Physician as part of a team that performs high quality and timely scientific and operational analysis of pharmacovigilance information. This position works closely with the Safety Systems & Information Management and Strategic Alliance, Compliance & Training groups as part of a matrix team to support the Therapeutic Area business unit by ensuring that pre- and post-marketed products are adequately supported from a safety standpoint.

Essential Functions: In conjunction with PVRM Lead, perform safety surveillance activities within a product(s) team that include:

Signal Detection and Medical Surveillance Activities.

a. Independently evaluates data, identifies opportunities and risks, weighs alternatives and presents analyses to Medical Director for review.

b. Organize planned and ad hoc safety review activities - Obtain data for signal assessment (e.g., Oracle AERS, FDA AERS data, literature search); generate/request listings, identify cases, prepare initial assessment for review and finalization by Medical Director, follow-up on meeting outcome (as needed), ensure the appropriate maintenance of relevant documentation.

c. Quarterly AE Review of Clinical Trials - Perform first iteration of listings review, discuss issues with Medical Director.

d. Lot Review - Prepare listing and table for Medical Director review and summary.

e. Literature Surveillance - Perform review of literature with appropriate documentation; identify case reports as well as new safety information and alert Medical Directors, as appropriate.

Risk Management/Post-Approval Commitments.

a. Under supervision of the Medical Director, contribute to creation, annual review and update of RMPs as needed.

b. Follows up on safety related post-approval regulatory commitments for assigned products.

Aggregate Reports

a. PSURs.

•Draft/Collect Sections 1 through 8

•Work with others to determine topics for discussion in Section 9; prepare first draft of Section 9 for Medical Director review.

•Follow-up on issues identified in regulatory responses (e.g., assessment reports).

b. US Periodic Reports – Obtain data and develop first draft.

Clinical Trial Support

a. Oversee and perform case processing activities working with CTSA to ensure consistency, as needed.

b. Investigator Brochure (IB): Contribute to creation, review and updates of IB.

c. Aggregate Reports for investigational products such as DSURs, ASRs, IND Annual - collect, collate, format and draft PVRM data contribution.

d. IND Safety reports - analysis of similar events - Collect, collate, format and draft data contribution and perform first review.

e. Database Lock - Perform reconciliation and signoff.

f. Clinical trial safety review.

Regulatory

a. Regulatory Requests/Responses - Pull data and draft response in consultation with Medical Director prior to management review.

b. Submissions - Contribute to creation and review of 2.5, 2.7.4 of CTD; Integrated Summary of Safety; proposed labels for submissions.

c. Manage pharmacovigilance related activities associated with proposed safety label changes.

Other

a. Effectively manages department workload and product responsibilities.

b. Manage respective outputs for assigned product(s) ensuring on-time delivery of quality documents. Ensures timely decision-making, problem solving, follow through and appropriate managerial elevation of issues.

c. Represents functional area on routine issues and facilitates multidisciplinary communications.

Minimum Education Requirements: Bachelors

Experience Required: 3 - 5 Years

Knowledge & Skills (General and Technical): • Master Degree or PhD in Medical Science, Pharmacy or Nursing preferred.

• Minimum of 4-6 years in a pharmaceutical organization or related industry with a minimum of 2-3 years pharmaceutical experience in a clinical safety or regulatory affairs departments required.

• Minimum of 2-3 years of medical writing experience (Prefer experience in writing pharmaceutical reports such as PSURs, Clinical Study Reports, safety sections of the ISS and/or Common Technical Document, or white paper) and/or experience in Medical Surveillance and Risk Management.

• Proven understanding of clinical disease state and implications of treatment.

• At ease with data and statistics.

• Proven ability to communicate effectively (verbal, presentation at group meetings, etc).

• Proven experience with project management (formal or informal).

• Strategic thinking, organizational leadership, results-oriented performance, team player.

• Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines) and Risk Management.

• Excellent interpersonal skills, including ability to work effectively, cross culturally and cross functionally.

• Excellent written and verbal communication.

Other Requirements (Licenses, Certifications, Specialized Training, Physical or Mental Abilities Required):

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a computer for extended periods of time.

Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer

Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.