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careers@globalpharmatek.com

We aspire to be the Clinical Research Organizations that is a solid contributor in driving more customer projects in the market or is an important decision maker in the whole industry. In brief, we want to be the partner of choice in the process of drug development. That is our core vision, which drives all our efforts and for that we never cut down the need to hire more talented people and achieve that goal.

If you share our aspirations then join us today. By being a part of us, you will be able to bag the chance to work in a spectacular environment with the most intelligent and innovative team, moreover, you will be making a contribution that will help shape a better industry!

Current Openings

Compliance Manager

Job Description:
Global PharmaTek, LLC has job openings for Compliance Manager (Pharma). Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Develop innovative value propositions within the clinical research and life sciences space to meet global regulatory compliance relating to pharmaceutical, bio-pharmaceutical, and medical devices manufacturing. Provide leadership and technical decision-making for various stakeholders, management, and high-level technical personnel regarding cGMP, GCP, ICH compliance, regulatory audits, strategy, clinical, and quality systems for projects and strategic activities. Author, review, and implement SOPs to ensure compliance with current international regulatory standards and cGMP. Lead cross-functional analytical teams in the resolution of business or systems issues in pharmaceutical manufacturing. Create and develop relationships with clients and identify future opportunities. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master’s degree or foreign equivalent in Computer Science, Engineering (any), Business Administration, Life Sciences, or a related scientific/quantitative discipline.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 17GPH13; EOE

Location: Edison, NJ

Apply

Sr. Pharmacovigilance Scientist I

Job Description:
Global PharmaTek, LLC has job openings for Sr. Pharmacovigilance Scientist I. Jobs located in Edison, NJ. Review non-serious and serious AEs and aggregate AE listings. Prepare signaling meeting presentations in collaboration with the team, including review of events of interest, initial trending of AEs, set thresholds for escalation, and preparation of meeting minutes. Monitor the safety profile of assigned compounds to identify any safety signals and support execution of plans for signal evaluation. Safety Committee preparation and documenting of meeting minutes. Review urgent safety issues and escalate to MD. Initial preparation of RMP and PV plans. Literature search terms and summary results review and escalation to MD. Responsible for clinical study such as IB and NDA, safety benefit-risk review, and ad hoc reports. Aggregate report review and input for assigned products such as PSURs, PBRER, PADER – triage to MD. Interact with vendor contracted to author aggregate reports for specific products, as needed. In collaboration with the team, contribute to and help coordinate responses to safety questions from regulatory authorities for assigned products. Contribute to initiatives for process improvement and consistency regarding aggregate reporting, signal management, and responding to ad hoc safety questions. Requires Master’s degree or foreign equivalent in Computer Science, Engineering (any), Public Health, Life Sciences, or related.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 17GPH12; EOE

Location: Edison, NJ

Apply

Senior Validation Engineer I

Job Description:
Global PharmaTek, LLC has job openings for Sr. Validation Engineer I. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of problems for various pharma and other facilities. Prepare validation and performance qualification protocols for new or modified processes, systems, or equipment for various production types. Coordinate the implementation or scheduling of validation testing with affected departments and personnel. Create, populate, and maintain databases for tracking validation activities, test results, and validate systems. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master’s degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences, Pharmacy, Chemistry, Biochemistry, Biology, or a related life sciences discipline.

Mail resume with cover letter to Global PharmaTek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH14; EOE

Location: Edison, NJ

Apply