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Pharmacovigilance Medical Director

Takeda Pharmaceuticals International GmbH

This is a Full-time position in Boston, GA posted December 1, 2020.

n n nnThe health and safety of our employees and candidates is very important to us.

Due to the current situation related to the Coronavirus (COVID-19), we’re leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda.

As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey.

If so, one of our colleagues will explain how these tools will be used during the recruitment process.

Thank you.nn nn *Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers.

See below or here for more info.

nn nnTakeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people’s lives.

It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines.

Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.nn nnAs one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide.

We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

The Greater Boston Area is headquarters to many of our Global and US business units.nn nnWe are a passionate team doing important work that impacts patients’ lives.

If you are driven to create better health and a brighter future, join us!nn nSuccessn nnWhat makes a successful member of our team?

Check out the traits we’re looking for and see if you have the right mix.nn nLife at Takedan nA Global Top Employern nnRecognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer ® status for 2020.nn nn Job ID R0022007 Date posted 12/10/2020 Location Boston, Massachusetts nn nnAre you looking for a patient-focused company that will inspire you and support your career?

If so, be empowered to take charge of your future at Takeda.

Join us as a PV Medical Director in our Cambridge, MA office.nn nn OBJECTIVE:  nn Support marked products: 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 Support Therapeutic Lead: Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs nn ACCOUNTABILITIES:  nn Expectation of GSL role for marketed compound(s) 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 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 nn EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: nn 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 Minimum of 8 years of 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 nn WHAT TAKEDA CAN OFFER YOU: nn 401(k) with company match and Annual Retirement Contribution Plan Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days nnCheck out where you could ben working if you apply.nn nJob Seekers: Protect yourself against identity theftn nnPlease be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information.

They visit job-related websites and invite candidates to online chats.

During the chat, they press job seekers to provide bank account information and Social Security numbers.nn nnCopyright 1995-2019 Takeda Pharmaceutical Company Limited.

All rights reserved.nn n n

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