- Merck & Co. (Rahway, NJ)
- Job Description Associate Director, Regulatory Submissions Archive Operations - Location: Rahway, NJ (Hybrid role - onsite 3 days per week required) - Functional ... (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director of Regulatory Submissions Archive Operations serves as the Business System… more
- Merck & Co. (Montgomery County, PA)
- …in the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... primary liaison with commercial, medical affairs, market access, legal/compliance, pharmacovigilance , and external partners to ensure integrated program deployment.Develop… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …safety signals, adverse events, and efficacy data in collaboration with pharmacovigilance teams. Target Product Profile (TPP) Contributions: Develop and refine TPPs ... by outlining desired product characteristics such as indications, target population, dosing regimen, safety profile, and clinical efficacy.Align TPPs with regulatory requirements and commercial goals to guide product development strategies. Due Diligence… more
- GE HealthCare (IL)
- **Job Description Summary** The Pharmacovigilance Agreement Associate , working on the Global Pharmacovigilance Team, will be responsible for supporting the ... preparation and maintenance of GE HealthCare Pharmacovigilance Agreements (PVAs), Safety Data Exchange Agreements (SDEAs), and other related contractual … more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Manager, Pharmacovigilance Department: Pharmacovigilance Location: Elmwood Park, NJ START YOUR APPLICATION ... About the Job This role reports to the Regional Pharmacovigilance Head - North America. The successful individual will...assist with managing the safety tasks performed by a Pharmacovigilance provider with focus on efficient, accurate and timely… more
- Lilly (Indianapolis, IN)
- …of experience in the pharmaceutical industry and/or demonstrated understanding of pharmacovigilance or clinical research or similar highly regulated environment. + ... 2+ years of demonstrated experience in data, reporting, analytics, and processes/systems/tools. **Other Information/Additional Preferences:** + Demonstrated understanding of the PV safety system and business processes + Demonstrated working knowledge and… more
- PSKW LLC dba ConnectiveRx LLC (Whippany, NJ)
- …direct supervision of the department manager or supervisor, the Specialist, Pharmacovigilance is focused on meeting ConnectiveRx's obligations for Drug Safety ... that ConnectiveRx operates in a constant state of compliance with Pharmacovigilance activities. Responsibilities + Reviews written Adverse Event and Product Quality… more
- AssistRx (Orlando, FL)
- …Leadership in order to effectively maintain program operations and goals. + Monitoring associate calls and providing feedback to program managers on associate ... strengths/coaching opportunities + Reviewing associate case records to ensure program metrics are met + Preparing call center reports and tracking service trends + Participating in the creation and maintenance of program SOP's + Assisting with user… more
- Taiho Oncology (Princeton, NJ)
- …Value Proposition: Embark on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of pharmacovigilance ... on your experience in our rapidly evolving organization. Position Summary: The Associate Director, PV Sciences role will lead medical surveillance activities for… more
- Takeda Pharmaceuticals (Boston, MA)
- …**OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business ... affiliate and enables them to deliver their clinical research and pharmacovigilance -related regulated activities with high compliance and agility. + Establish and… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **Position Overview** The Associate Director is responsible for ensuring that Primary Market Research, Competitive Intelligence, and Data ... regulations, Company policies and procedures, and governing body rules and standards. The Associate Director will: + Be a champion for ethical and compliant Primary… more
- Ascendis Pharma (Princeton, NJ)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director, ICSR Management Team reports to the Director, Head, ICSR Management Team ... + Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners /… more
- Astellas Pharma (Northbrook, IL)
- …diverse rotations-Clinical Development (12 months), Medical Affairs (6 months), and Pharmacovigilance (6 months), Participants will gain hands-on exposure to key ... working while fostering collaboration across commercial and Medical teams. 1. ** Pharmacovigilance (6 months)** + Develop hands-on experience in safety monitoring and… more
- AbbVie (North Chicago, IL)
- …detection, validation, and assessment. Interpreting regulations related to pharmacovigilance , supporting all patient safety activities. Responsibilities: * ... pharmaceutical/biological/drug-device combined products; contributes to the authorship of key pharmacovigilance documents, including but not limited to medical safety… more
- System One (East Windsor, NJ)
- Job Title: Quality Compliance Associate Location: East Windsor, New Jersey Type: Contract Compensation: $26 - $36 per hour Contractor Work Model: Onsite Hours: 8/9 ... Sterile Injectable Products Responsibilities: + Under the oversight of the Associate Manager of Quality Assurance (QA) Compliance, this position will be… more
- ThermoFisher Scientific (Greenville, NC)
- …background check, which includes a drug screening. Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical ... and oversight of all contracted services. **Discover Impactful Work:** The Associate /Medical Director provides medical oversight of clinical trials to ensure company… more
- CSL Behring (King Of Prussia, PA)
- …therapies that make a meaningful difference worldwide. We are looking for a ** Associate Director,** **Case Management Intake & Submissions** to join our R&D team. ... if required. . Close collaboration with WAVES team, IT, International Pharmacovigilance (IPV) & Capability Building and other interface functions to identify… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the ... compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by… more
- Lilly (Indianapolis, IN)
- …its position as a leader in pharmaceutical innovation, we are seeking an Associate Vice President (AVP) - Patient Safety Technology & Development Transformation to ... **This role encompasses four strategic imperatives:** + **Patient Safety & Pharmacovigilance Technology:** Lead the enterprise strategy for drug safety technology… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** Director OR Senior Associate Director has responsibility for the pharmacovigilance risk management activities of marketed and/or investigational ... investigational compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Chair or support… more
