Lead Drug Safety Associate

Company: Cynet systems Inc
Location: Stamford
Posted on: September 13, 2020

Job Description:

Lead Drug Safety Associate - CSI-IS-025 - Stamford, CT We are looking for Lead Drug Safety Associate for our client in Stamford, CT

Job Title: Lead Drug Safety Associate

Job Location: Stamford, CT

Job Type: Contract

“W2 candidates are encouraged to apply. We are unable to sponsor H1b or work with third-party candidates at this time.”

Job Description:

The incumbent must have good knowledge of the PV end-to-end process and will leverage this knowledge to implement efficiencies/cost savings.

The incumbent will be responsible for the implementation, execution, training, continuous improvement, and oversight of matters pertaining to PV alliances and policies.

The incumbent will liaise with internal and external stakeholders, subsidiaries, Independent Associated Companies (IACs), business partners, and vendors as needed to establish and maintain policies as well as implement any corrective/preventive actions needed to ensure compliance.

Responsibilities:

Establishes and maintains departmental procedures; oversees the training and continuous improvement.

Support DSP in pharmacovigilance activities including signal detection and tracking activities, literature surveillance, oversight of medical review performed by an outsourced vendor.

Collaborate with DSP safety physicians with PV activities as assigned.

Writing safety analysis reports.

Oversight of medical review and aggregate report activities performed by outsourced vendors.

Support clinical project teams for investigational products; provide project teams providing expertise in PV activities.

Collaborate with Clinical Research and Development, Medical Affairs, Regulatory Affairs.

Provide Leadership in the development, implementation, and maintenance of robust procedures for PV activities within the DSP department.

Participate in the Safety Evaluation Group with local and global drug safety colleagues to monitor and discuss safety signal evaluation topics.

Contribute to the writing and compilation of PADERs, Annual reports, and PSURs/PBRER.

Author and review department SOPs as needed.

Participate in Regulatory Inspections, external audits, and investigator meetings.

Drug safety representative on client intradepartmental committee for review and approval of clinical trial protocol language and clinical study processes.

Acts as a Subject Matter Expert in PV regulatory inspections and internal/external audits.

Collaborates with internal stakeholders and client subsidiaries to establish and maintain the Corporate AE Policy.

Collaborate with Drug Safety Operations and Drug Safety Systems as needed, to ensure appropriate metrics per SOP.

Skills:

Up-to-date knowledge of PV regulations and best practices.

Thinks globally and considers present and future impacts when making recommendations.

Experience with PV vendor and business partner oversight and contract/agreement management.

Strong negotiation and problem-solving skills.

Analytical skills and attention to detail.

Accountability – takes ownership of deliverables.

Education and Experience:

This job requires a Bachelor’s degree (advanced degree preferred) in life science or healthcare (e.g. nursing, pharmacy) with 10 years of experience in a pharmaceutical/biopharmaceutical company and 7 years of Drug Safety experience.

Published at 08-04-2020

Viewed: 13 times

Today's Date:  Thu Aug 06 2020

Cynet Systems is an Equal Opportunity Employer

At Cynet Systems, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy (including childbirth, lactation, and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military, women, minority and veteran status, and any other characteristic protected by applicable law. Cynet Systems believes that diversity and inclusion among our teammates are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.

Keywords: Cynet systems Inc, Stamford , Lead Drug Safety Associate, Other , Stamford, Connecticut