[The logo is protected from the company]

Icon Clinical Research India Private Limited

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I - IV clinical studies. ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually st... Read More

Address      ICON Clinical Research No.56/4,Sharadha Towers(Unit II), 2nd floor Nandidurg Road Bangalore India
Website      www.iconplc.com
Holding      No Holding Details

View Company Page
Apply to job

Drug Safety Manager at ICON Clinical Research

Job title : Manager Drug Safety Job Location : Chennai This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. POSITION SUMMARY Ensure that projects within Medical and Safety run efficiently, accurately and in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors Ensure the daily project operations of assigned safety projects Provide project management on Drug Safety projects Oversee Drug Safety and Administrative staff, as assigned JOB FUNCTIONS/RESPONSIBILITIES: Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance. As a Manager, the employee is expected to recognize the importance of and create a culture ofprocess improvement with a focus on streamlining our processes adding value to our business and meeting client needs. *Travel (up to approximately 15%) domestic and/or international as applicable *Ensure all project safety activities are completed in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes *Keep management appraised of any potential/actual study or staffing issues and develop solutions for same Develop and implement department training *Assist in training of other departments, as requested *Maintain quality review metrics and attend project quality meetings, as required Assist with maintenance of project budgets and oversight by identifying out of scope activities *Assist upper management with resourcing and business development activities *Attend bid defence meetings, as requested *Manage small to mid-size drug safety projects, including Sponsor liaison, and management of timelines and budgets, as appropriate *Ensure audit readiness and/or MSS representation at audits *Develop safety plans, study specific procedures, and workflows for clients, as requested *Actively identify options for process improvement a *Supervise maintenance of project drug safety files as regionally applicable Coordinate any committee activities as applicable under supervision Perform other activities as identified and requested by management Supervision *Manage MSS projects in accordance with established timelines, budget, quality standards and/or contractual requirements *Develop supporting staff skills, encourage growth and provide regular performance feedback *Provide project and/or line management of assigned Drug Safety and Administrative staff *Serve as a mentor and role model for Drug Safety staff. QUALIFICATIONS/EXPERIENCE REQUIRED: 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.(US) A minimum of 8 years of relevant clinical research / pharmaceutical industry experience, preferably with at least 6 years experience in pharmacovigilance / drug safety. Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or Sponsors Demonstration of professional demeanour, judgment and discernment in interactions with clients, colleagues, and other staff Thorough knowledge of global safety processes and regulations Good knowledge of medical terminology and coding systems Very good computer skills Excellent organizational skills Excellent communication skills Very good presentation skills Very good ability to mentor staff Ability to work independently or lead study teams Ability to self-start and show initiative Detail oriented Fluent in written and verbal English EDUCATION REQUIREMENTS Medical/science background (nursing preferred) and/or bachelors degree or local equivalent. Benefits of Working in ICON Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career. Salary:Not Disclosed by Recruiter Industry:Pharma / Biotech / Clinical Research Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology Role Category:Medical Professional Role:Medical Officer

Other Job Information

Vacancy type:

Full Time

Contact Mode:

not provided

Fax:

not provided

Contact Name:

HR

Job Duration:

not provided

Phone:

not provided

Email:

ganga.ashok@docsglobal.com

News - Icon Clinical Research India Private Limited

Related Jobs

Occupational Therapist

xFULL-TIME SC LICENSE ELIGIBLE, OR CERTIFIED OCCUPATIONA ...   [more]

Employee Health & Benefits Consultant

DescriptionMercer is the global leader for trusted Human ...   [more]

Employee Health & Benefits Consultant

DescriptionMercer is the global leader for trusted Human ...   [more]

Employee Health & Benefits Consultant

DescriptionMercer is the global leader for trusted Human ...   [more]

Employee Health & Benefits Consultant

DescriptionMercer is the global leader for trusted Human ...   [more]

Employee Health & Benefits Consultant

DescriptionMercer is the global leader for trusted Human ...   [more]

Employee Health & Benefits Consultant

DescriptionMercer is the global leader for trusted Human ...   [more]

Employee Health & Benefits Consultant

DescriptionMercer is the global leader for trusted Human ...   [more]

Expand

Collapse