- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Medical Writing will be responsible for developing and ... implementing medical writing strategies and operational plans to support Formation...regulatory documents (meeting and briefing packages, regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and ... individual case medical review, risk management, aggregate safety reports, and translational medical safety...of the CoE group comply with Good Clinical and Pharmacovigilance Practices, as well as all relevant internal and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …delivery of laboratory data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and other ... advanced knowledge of medical terminology capture and reporting of safety data, pharmacovigilance , industry best practices, and relevant regulatory… more
- Bristol Myers Squibb (San Diego, CA)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Executive Director , Head of Pharmacovigilance - Safety Science, is responsible for ... and Stakeholder Engagement + Partner with clinical, regulatory, and medical affairs teams to integrate safety insights...equivalent (MBBS etc) + 10+ years of experience in pharmacovigilance , safety science, or related area within… more
- Takeda Pharmaceuticals (Boston, MA)
- …Inc. for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Medical Director Pharmacovigilance , Rare Disease & PDT **POSITION ... : Takeda Development Center Americas, Inc. is seeking a Medical Director Pharmacovigilance , Rare Disease...agencies and ethics committees, MAAs, NDAs, and BLAs; provide medical safety expertise, medical interpretation,… more
- Sumitomo Pharma (Raleigh, NC)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Medical Director .** The Associate Medical Director will ... PVRM support for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout… more
- Takeda Pharmaceuticals (Boston, MA)
- …Purpose:** + Ensures adequate training support to all functional areas within Patient Safety & Pharmacovigilance (PSPV) in a Pharmacovigilance (PV) regulated ... of 5 years prior experience in pharmaceutical industry in a drug safety / pharmacovigilance global setting + Experience in developing procedural documents and… more
- Lilly (IN)
- …to make life better for people around the world. **Purpose:** The Sr. Director GPS Strategy is responsible for developing and executing strategic initiatives to ... the GPS organization. This role oversees an integrated Global Patient Safety transformation agenda, emphasizing innovation, simplification, and providing project and… more
- Lilly (Indianapolis, IN)
- …technology, automation, and systems strategy for all functional areas in GPS. The Sr. Director / Executive Director Safety Data Scientist provides strategy, ... make life better for people around the world. **Sr. Director / Executive Director - Safety...elevate the profile of GPS and the science of pharmacovigilance as an essential obligation of the company by… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. Associate Director , Global Patient Safety Medical Science reports to Head of GPS ... Head of GPS Medical Science for drug safety and pharmacovigilance activities for ensuring corporate...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- BeOne Medicines (San Mateo, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs ... pharmacovigilance and epidemiological analysis + Actively leads BeiGene safety in face-to-face regulatory meetings + Actively leads and...on the program / portfolio being led. The Executive Medical Director serves as Product Safety… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). ... company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will... Safety Board and similar forums. The Senior Medical Director will be a key player… more
- BeOne Medicines (Emeryville, CA)
- …regulatory-required periodic reporting. Physicians in this role are also expected to provide medical safety assessment. In this role, you will apply effective ... General Description: _The Director , Safety Scientist supports assigned compounds...performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely… more
- Lundbeck (Deerfield, IL)
- Medical Director Global Patient Safety (GPS) US Requisition ID: 5424 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, ... data analyses and advancing methodologies in line with healthcare trends + Providing medical safety input into the design and conduct of pharmacoepidemiology and… more
- Takeda Pharmaceuticals (Boston, MA)
- …process in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) ... the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ensuring the… more
- Rhythm Pharmaceuticals (Boston, MA)
- …barriers, together. Opportunity Overview Rhythm seeks an experienced and highly motivated Director of Medical Writing (MW) who can independently develop as ... well as oversee the development and advancement of clinical, regulatory, medical and safety documents spanning across the development lifecycle. Under minimal… more
- United Therapeutics (Phoenix, AZ)
- …enjoy being part of a collaborative team. The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case safety ... to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. **Summary** The Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and ... individual case medical review, risk management, aggregate safety reports, and translational medical safety...of the CoE group comply with Good Clinical and Pharmacovigilance Practices, as well as all relevant internal and… more
- Takeda Pharmaceuticals (Boston, MA)
- …for presentations to the Takeda Safety Board and similar forums. The Senior Medical Director will be a key player in the preparation and presentation of ... directly manage a group of GSLs and PV Scientists responsible for overseeing the medical safety profile for assigned products. + Interacts with and influences… more
- AbbVie (Philadelphia, PA)
- … Safety Lead for one or more products under the direction of Group Medical Director Medical Safety Evaluation. Supporting assigned product with ... safety data, including but not limited to, medical safety assessments, parts of submission dossier.../ DO, not required *5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry… more
