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SDEA Manager/ Pharmacovigilance Alliance Manager

Job Description

About the Role
As the SDEA Manager, you will collaborate with internal stakeholders and external business partners in the end-to-end lifecycle management of Safety Data Exchange Agreements (SDEA):
* Lead the preparation, negotiation and conclusion of SDEAs relating to Development and Commercial partnerships.
* Support the establishment and maintenance of SDEA related business processes, standards and systems.
* Act as a key contact point on all matters relating to SDEAs with internal stakeholders (e.g. Safety, Quality, Regulatory, Business Development, Alliance Managers, Supply, Commercial, Legal, Affiliates) as well as external business partners.
* Ensure oversight on all assigned SDEAs, contractual obligations and associated deliverables throughout the lifecycle of the partnership.
* Ensure compliance with company guidelines, legal and regulatory requirements and industry practice.
* Actively support audits and inspections as well as resolution of CAPAs.

About You
You should have:
* Bachelor's degree is required, Master's degree is preferred.
* At least 2 or more years' experience in pharmacovigilance and/ or regulatory, quality, legal, contract management related role.
* Good working understanding of global clinical and pharmacovigilance regulations and guidelines.
* Understanding of contractual concepts and terminology. Experience drafting, interpreting and managing agreements with business partners is a plus.
* Strong negotiation and problem solving skills.
* Effective time management skills and ability to manage potential shifts in priorities.
* Excellent oral and written communication skills - Proficient in English.
* Good analytical skills and attention to detail.
* Strong team orientation and ability to work autonomously in a cross-functional and cultural environment




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email [email protected] .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 

Job Snapshot

Location US-NC-Raleigh
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Biotech, Health Care, Pharmaceutical
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Company Overview

Aerotek

We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With more than 230 non-franchised offices, Aerotek’s 6,000 internal employees serve more than 300,000 contract employees and 17,000 clients every year. To learn more, visit Aerotek.com. Learn More

Contact Information

US-NC-Raleigh
Brian Hoenig
9193798245
Snapshot
Aerotek
Company:
US-NC-Raleigh
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Biotech, Health Care, Pharmaceutical
Store Type:

Job Description

About the Role
As the SDEA Manager, you will collaborate with internal stakeholders and external business partners in the end-to-end lifecycle management of Safety Data Exchange Agreements (SDEA):
* Lead the preparation, negotiation and conclusion of SDEAs relating to Development and Commercial partnerships.
* Support the establishment and maintenance of SDEA related business processes, standards and systems.
* Act as a key contact point on all matters relating to SDEAs with internal stakeholders (e.g. Safety, Quality, Regulatory, Business Development, Alliance Managers, Supply, Commercial, Legal, Affiliates) as well as external business partners.
* Ensure oversight on all assigned SDEAs, contractual obligations and associated deliverables throughout the lifecycle of the partnership.
* Ensure compliance with company guidelines, legal and regulatory requirements and industry practice.
* Actively support audits and inspections as well as resolution of CAPAs.

About You
You should have:
* Bachelor's degree is required, Master's degree is preferred.
* At least 2 or more years' experience in pharmacovigilance and/ or regulatory, quality, legal, contract management related role.
* Good working understanding of global clinical and pharmacovigilance regulations and guidelines.
* Understanding of contractual concepts and terminology. Experience drafting, interpreting and managing agreements with business partners is a plus.
* Strong negotiation and problem solving skills.
* Effective time management skills and ability to manage potential shifts in priorities.
* Excellent oral and written communication skills - Proficient in English.
* Good analytical skills and attention to detail.
* Strong team orientation and ability to work autonomously in a cross-functional and cultural environment




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email [email protected] .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 
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SDEA Manager/ Pharmacovigilance Alliance Manager Apply now