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Medical Director Pharmacovigilance

Kelly Services


Location:
Cambridge, MA
Date:
04/18/2018
2018-04-182018-05-17
Job Code:
US33MXMP_BH1427745
Categories:
  • Healthcare
  • Monitoring
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Job Details

Job Title Medical Director Pharmacovigilance

Jobid US33MXMP_BH1427745

Location: Cambridge, MA, 02238, USA

Description Kelly Services is seeking a **Medical Director Pharmacovigilance** for our leading pharmaceutical client in Cambridge, MA for a 1 year W2 contract opportunity.

Job Description:

**Position Title:**

**Medical Director, Pharmacovigilance**

**Function: Research and Development**

**Department: Pharmacovigilance**

Reporting to Executive Medical Director, GI Therapy Area Lead, Global Patient Safety

**1 Year Assignment**

**OBJECTIVE:**

Support developmental programs, including both early and late stage development as required. Responsible for the oversight of signal detection and risk management activities for designated global/regional product s , together with global safety lead responsibly as appropriate. Supporting Therapeutic Lead Line management responsibilities for junior physicians and/or scientists.

Flexible to support compounds/initiatives outside of primary therapeutic area s as directed by business and departmental needs

**ACCOUNTABILITIES** :

Expectation of GSL role for compound s both in development and marketed in close association with the TAL. Company wide safety expert for his/her compound responsibilities Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for own compounds with input for other compounds as needed. Serving in a leadership capacity for complex and strategically important programs.

Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety IAS for CTDs etc.

Training and mentoring of Pharmacovigilance Physicians and Specialists.

Perform activities required to serve as Global PV physician:- Review and oversight of safety data, both non-clinical and clinical- Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities

- Interactions with external experts and regulatory agencies and partner/co-development companies

- Review of safety data and participate in dose escalation decisions- Authorship and sign off of Safety Monitoring Plan/Risk Management Plan

- Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators

- Direct the set up of safety procedures and development of safety exchange agreements for co-development projects.

Maintain professional knowledge and accreditation by active participation in continuing medical education activities

**SCOPE OF SUPERVISION:NUMBER SUPERVISED WORKERS**

Direct In-DirectEmployees 0 0

Non-Employees 0 0

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS** :

Qualified physician License, e.g. GMC registered, preferred Knowledge of principles of epidemiology and statistics.

Critical thinking and analytical skills and ability to make high level decisions

Excellent oral and written communication skills including ability to present to large internal/external groups

Good level of computer literacy with Microsoft applications

**LICENSES/CERTIFICATIONS: PHYSICAL DEMANDS:**

Routine demands of an office based environment.

**TRAVEL REQUIREMENTS:**

Estimated 5-10 times per year including international travel

ADDITIONAL US SPECIFIC INFORMATION :

Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine

**Why Kelly?**

**For immediate consideration, if you meet the above requirements, please email a current copy of your CV to meghan.porter@kellyservices.com or click 'apply now'.**
**You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place.**

**Let Kelly fuel your career—connect with us today.**


_*Available for purchase and administered by a designated third-party vendor_

_Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, and Gender Identity, and is committed to employing a diverse workforce._

**Why Kelly** **®** **?**

At KellyServices ® , we work with the best. Our clients include 95 of the Fortune100 ™ companies, and more than 70,000 hiring managers rely on Kelly annually to accessthe best talent to drive their business forward. If you only make one career connection today, connectwith Kelly.

**AboutKelly Services** **®**


As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 peoplearound the world and have a role in connecting thousands more with work through our global network oftalent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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