Pharmacovigilance-2025 Job at Gan & Lee Pharmaceuticals, Bridgewater, NJ

SWQvdVV0emFpajJOZnNvWndHejdPU25Hbmc9PQ==
  • Gan & Lee Pharmaceuticals
  • Bridgewater, NJ

Job Description

Job Description

Job Description

Summary
This position is responsible for overseeing pharmacovigilance activities to ensure the safety and compliance of pharmaceutical products. The role involves monitoring, detecting, assessing, and reporting adverse drug reactions (ADRs), as well as ensuring effective risk management and regulatory compliance across domestic and international markets. This individual will collaborate with clinical operation teams, regulatory authorities, and other stakeholders to support the safety and continued benefit-risk evaluation of products. The position reports to the head of Clinical Science.

Education and Experience
  • Master’s degree in life sciences or a related field with 2+ years of of pharmacovigilance or drug safety experience in the pharmaceutical or biotech industry.
Skills and Qualifications
  • In-depth knowledge of global pharmacovigilance regulations and drug safety practices, including FDA, EMA, and ICH guidelines.
  • Strong analytical and problem-solving capabilities, with meticulous attention to detail and the ability to accurately interpret and assess safety data.
  • Proficiency with pharmacovigilance systems and databases (e.g., Argus, ArisGlobal). Proficient in data processing software, safety databases, regulatory submission systems, and MedDRA coding.
  • Skilled in presenting and critically discussing safety data in both internal and external settings.
  • Extensive experience providing safety inputs for multiple global clinical trials.
  • Demonstrated ability to manage multiple tasks simultaneously, prioritize effectively, and identify key issues.
  • Outstanding communication skills, with a proven ability to build and maintain strong relationships with regulatory authorities, internal teams, and external partners.
Responsibilities
  • Formulate and optimize pharmacovigilance processes and strategy to improve the efficiency and quality of safety assessments and monitoring.
  • Oversee the collection, evaluation, analysis, and reporting of ADRs, ensuring compliance with global drug safety monitoring standards.
  • Lead drug safety risk assessments, signal detection activities and the development and implementation of Risk Management Plans (RMPs), promptly identifying and evaluating potential drug safety risks.
  • Lead and oversee the management of drug safety data, pharmacovigilance documentation and record, ensuring the accuracy and completeness and confidentiality.
  • Participate in pharmacovigilance external audits and regulatory inspections, ensuring compliance with all applicable regulations.
  • Lead the preparation and review of drug safety reports (e.g., PSUR, PBRER, DSUR) to ensure compliance with global regulatory standards. Assist in the preparation of safety narratives and regulatory submissions
  • Ensure accurate documentation and archiving of pharmacovigilance data in safety databases. Provide regular drug safety updates to management, regulatory agencies, and partners, ensuring transparency and compliance in pharmacovigilance activities.
  • Collaborate closely with Clinical, Regulatory Affairs, and other departments to ensure timely and effective communication and sharing of drug safety information.
  • Provide training to internal teams and external partners on pharmacovigilance processes and requirements.

 

Powered by JazzHR

pCLRLgtw9U

Job Tags

Similar Jobs

Abbeville Dentistry

General Dentist- $200,000 One Year Income Guarantee-$50,000 Sign On Bonus Job at Abbeville Dentistry

 ...sharing abundantly and building relationships. About the Position We are looking for passionate and dedicated general practice dentists who love creating long-lasting relationships with their patients. As a general dentist with Mortenson Dental Partners, youll have... 

Marathon Staffing

Warehouse Laborers! (UFPR) Job at Marathon Staffing

Production Helpers!FAST Apply & Get Hired ASAP!! Start a new career today!You can apply today and be scheduled ASAP for an orientation.Due to rapid growth, Marathon is Hiring Immediately reliable Team Members to work in Pallet Assembly Line at a local lumber company... 

Paramount Pictures

Director, Global Threat Management (Production Security) Job at Paramount Pictures

Director, Global Threat Management (Production Security) FacilitiesFull-TimeOn-SiteOverview & Responsibilities :This position is a Key Subject Matter Expert (SME) within Global Threat Management responsible for ensuring the continual and effective secure operations... 

Maxion Research

Paid Consumer Insights Analyst (Apply in minutes) Job at Maxion Research

 ...:**- A working camera on your smartphone or a webcam on your computer isrecommended.- Reliable internet connection for seamless participation...  ...efficiently.- Willingness to learn and develop skills for remote work success.**What Youll Enjoy:**- Participate in online... 

Crown Health Care Laundry Services

CDL A Driver Job at Crown Health Care Laundry Services

 ...Job Description Class A CDL Route Driver Are you an over-...  ...0 per week! This includes: Free Dental Free Vision Medical...  ...Two years Class A CDL driving experience We are PROUD to...  ...worked. Our drivers will load and unload their trucks of linen carts.