Pharmacovigilance Safety Scientist (2018-29252)

Comrise Horsham , PA 19044

Posted 5 months ago

Job Description

POSITION SUMMARY:

The Scientist will be responsible for assigned tasks related to core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (small to medium volume, standard complexity). Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. The Scientist will partner with team members, stakeholders, and a vendor.

PRINCIPAL RESPONSIBILITIES:

85% of the time:

Ensure timely, quality deliverables for assigned tasks related to core deliverables with oversight as appropriate

Collaborate with PVER team members to perform assigned tasks, Interact with other stakeholders (e.g Safety Surveillance Physician (SSP), Medical Safety Officer (MSO)) on relevant deliverables

Initiate/conduct searches of internal and external databases

Perform aggregate safety analysis and case level review

Author/contribute to the preparation of core safety deliverables

Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met as appropriate for assigned tasks

Partner with vendor to develop reports/deliverables

15% of the time:

Training/Meetings/Department Initiatives

Participate in department training

Training of task or process-related activities

Participate in department initiatives as appropriate

EDUCATION & EXPERIENCE REQUIREMENTS:

Bachelors Degree in Health or Biomedical Science (3-5 years industry experience or equivalent)

Advanced Degree Preferred in Health or Biomedical Science (2 years industry experience or equivalent)

Clinical/Medical writing or PV experience preferred

Strong English verbal and written communication skills

OTHER REQUIREMENTS:

Scientific Skillset: Analytic and Conceptual Skills

Independence: Minimal independence; (Contributor/Co-lead)

Knowledge (Product and Regulations): Safety Management Team (SMT) support when needed

Awareness of applicable global, regional, and local regulatory requirements (e.g., ICH guidelines)

Company Description

Comrise is the bridge to first-rate talent for organizations that recognize the value of their workforce. With locations in the U.S., China, and Hong Kong, we help our clients reach far and wide for both local and international resources which yield the highest return on their human capital investments.Headquartered in New Jersey since 1984, Comrise is a staffing, consulting and enhanced search technology company. For over 30 years we have delighted our clients and consultants by focusing on customer satisfaction, innovation and flexible workforce solutions. By combining our global networks with our outstanding local offices, Comrise provides high quality executive search, temporary and temporary to permanent staffing solutions, and cross border placement services.
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
RN (NonClinical) Customer Service Representative

C3i Solutions

Posted 4 days ago

VIEW JOBS 9/19/2018 12:00:00 AM 2018-12-18T00:00 At C3i Solutions, we are committed to providing an incredible experience — that starts with you. When you join our team, you become part of a network across the world delivering solutions for the most trusted healthcare brands, every day. As our company grows, we're looking for you to grow with us. We want people who bring their own personality, strengths and talents to create something exceptional. People who will gain more experience than they could have ever imagined when they walked through the door. People who are ready to experience the world like never before. If you're ready to experience opportunity, join us. Summary: Provide premier customer service on inquiries, processing orders, explaining client products, and handling complaints in a prompt, courteous, clear and concise manner. Essential Duties and Responsibilities include the following. Other duties may be assigned. * Confers with internal and/or external customers in order to provide information about products and/or services such as processing customer requests, orders, cancel accounts or obtain details of complaints over the phone, by email, live chat, social media or other method of communication. * Resolves customer questions and concerns effectively and efficiently by actively listening, communicating clearly and concisely, and assuring customer understanding. * Ensures customer satisfaction and loyalty by consulting with customers, assisting customers, and resolving a wide variety of customer requests, inquiries, and complaints. * Assists with product or service related tasks and activities, which may include order processing, invoicing, researching accounts, order history, handling returns, client program policies and opening new accounts. * Keeps records of customer interactions and transactions, recording details of inquiries, complaints, comments and actions taken. * Builds and maintain business relationship with clients by providing prompt and accurate service so as to promote customer loyalty for the client. * Documents Adverse Events and Quality Complaints. * Obtains and examines all relevant information to assess validity of complaints and to determine possible causes. May make outbound calls related to the product or service, and/or in follow-up to a customer inquiry. Supervisory Responsibilities This job has no supervisory responsibilities. Job Specifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience Current RN license. Previous pharmaceutical call center experience preferred. Previous product quality and/or pharmacovigilance experience desired. Language Skills: Ability to read and interpret documents such as safety rules, standard operating procedures (SOPs) or other job aids, to write routine correspondence, and to effectively present information in a one-on-one, small or large group situations, to customers, clients and associates. Reasoning Ability: Ability to apply common sense understanding to carry out instructions provided in written, oral or diagram form and to deal with problems involving several concrete variables in standardized situations. Computer/Technical Skills Proficient knowledge of Microsoft Office products. Familiarity with use of Microsoft Office Suite 2010. Dexterity navigating multiple databases. Other Skills and Abilities Ability to manage difficult, irate or emotional situations while maintaining composure; ability to multi-task; excellent time and process management skills; ability to handle conflict and balance the needs of the program and the team; demonstrates strong leadership skills. Strong customer relations experience desired. Inbound call center experience desired. Other Qualifications This position may require participation in and possible travel to training sessions and other off-site events. Physical Demands & Work Environment The physical demands and work environment characteristics described here are representative of those that an employee encounters and/or must successfully complete in order to perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, talk and hear. The employee must occasionally lift and/or move up to 10 pounds. The noise level in the work environment is usually moderate. C3i Solutions is an Equal Opportunity Employer - EOE, M/F, D/V C3i Solutions Horsham PA

Pharmacovigilance Safety Scientist (2018-29252)

Comrise