Pharmacovigilance Scientist

Following is the position details. Please let me know if you are available/interested so we can further discuss this position. Also email me your updated resume and contact number where I can call you or if you have any questions regarding the position my direct number is

732-429-1633.

Location: Cambridge MA,

Duration: 1 year+ (possible Extension)

Pharmacovigilance Scientist

Job Responsibilities:

• PV Scientist as a Subject Matter Expert supports Pharmacovigilance activities within SABR medical function.

• PV Scientists is responsible for overseeing and leading the process of safety signal management process, authoring / contributing to aggregate safety reports (PSURs, DSURs, etc.), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and conducting/overseeing Clinical Trial PV medical activities

KNOWLEDGE, SKILLS & ABILITIES:

Evaluate safety data and signals as part of ongoing pharmacovigilance activities, including synthesis of data from multiple sources and authoring signal evaluation reports.

• Manage literature review for safety information.

• Author responses to safety questions from regulatory authorities.

· Author and/or contribute to aggregate safety reports, as needed.

Interpersonal skills

• Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic matrix environment.

• Demonstrated strategic and critical thinking, ability to apply clinical judgment to interpret case information.

• Ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format including intermediate understanding and application of medical concepts and terminology.

• Strong organizational skills, including the ability to prioritize independently with minimal supervision.

Education:

Advanced Degree in biologic or natural science; or health case discipline

• Minimum 7 years Pharmacovigilance experience and strong drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations, as well as knowledge of case processing, expedited reporting rules, and safety database concepts.

• Minimum 5 years PV experience, including experience in aggregate safety reports and Safety signal management.

Feel free to forward my email to your friends/colleagues who might be available

• Minimum 7 years Pharmacovigilance experience and strong drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations, as well as knowledge of case processing, expedited reporting rules, and safety database concepts.

• Minimum 5 years PV experience, including experience in aggregate safety reports and Safety signal management.

Warm Regards,

Jay Kaushik

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

Direct: (732) 429 1633

Tel:(732) 549 2030x211

Fax: (732) 549 5549

http://www.irionline.com