Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.
Summary
Responsibilities
We are seeking a talented and motivated healthcare professional with some experience in pharmacovigilance to join our team. As an Drug Safety Associate, you will support our Pharmacovigilance group with a focus on operational execution of pharmacovigilance matters for our products in the US and Canada.
Essential Duties And Responsibilities
- Accountable for receipt, acknowledgement and communication of all adverse events reports received through mail from reporters and other manufacturers and vice versa.
- Performing triage of mails addressed to US pharmacovigilance team including but not limited to Adverse events, Product Complaints and Medical Information.
- Maintain and share log on receipt of all adverse event reports with reconciliation team.
- Prepare weekly report on the adverse event reports received through mail and fax from all sources (reporters, manufacturers).
- Accountable for ensuring Pharmacovigilance Trainings are undertaken, conducted and compliance is achieved.
- Accountable for evaluating pharmacovigilance training logs as applicable and ensuring all company employees and vendors are trained.
- Accountable for conducting and ensuring test calls and test fax are conducted on all Lupin toll free numbers in line with the SOPs.
- Support the North America PV lead in ensuring PV compliance in line with the DSRM SOPs.
- Partner with Global DSRM SDEA team, 3 rd party business units to ensure timely review and execution of Safety data exchange agreements.
- Author or support in review of pharmacovigilance SOPs in the North America (United States and Canada) as required.
- Partner with Global DSRM safety writing team and engage in development of risk management plans, additional risk minimization activities, implementation of RMPs and aRMMs for Canada as required
- Provide support, participation as required, maintain documentation, review and inputs on the safety aspects of REMS programs in the US to the North America PV lead.
- Escalate drug safety related information to North America PV lead.
- Support in routine pharmacovigilance activities as and when required.
Qualifications
Qualification Requirements / Education
- BA/BS in life sciences, M.S, R.N, Pharm D or similar preferred.
Qualification Requirements / Experience And Skills
- Detailed knowledge of PV regulations, and post-marketing obligations
- Adept at navigating in a sophisticated matrix environment spanning across various geographies to accomplish objectives with teamwork.
- Excellent oral and written communications skills interpersonal, problem solving - English is required.
- Detail-oriented, thorough, methodical, and able to follow the timelines.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin . No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific.
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