Manager, Drug Safety
ProClinical, in support of our client, are seeking an individual to fill the role of Drug Safety Manager, based in New York. The successful candidate will be directly responsible for executing US Adverse Event and PV activities, as required by FDA regulations.
- Receive, evaluate and file adverse event reports on marketed and investigational products.
- Communicate directly with patients, pharmacists, physicians, business partners and the FDA on matters related to adverse events, and drug safety.
- Interact with data intake and entry group(s) to ensure complete and quality output and provide guidance on follow-up as needed.
- Evaluate medical literature for adverse event and drug safety issues.
- Coordinate receipt and logging of Adverse Event data from all affiliates.
- Maintain a U.S. Adverse Event and safety database and coordinate distribution of relevant safety cases and data to other Country Safety Leads for reporting to regulatory authorities worldwide.
- Provide regular internal reports to applicable departments on the status of Adverse Event and reconciliation activities.
- Compile and submit regular periodic Adverse Event reports and submit individual safety reports to FDA.
- Develop and maintain SOPs needed for Pharmacovigilance Practices.
- Manage Product Quality Complaint issues related to Adverse Events and communicate with manufacturing sites regarding quality issues.
- Respond to Medical Inquiries from patients and pharmacists regarding drug usage and safety concerns.
- Monthly and ad hoc review of signal detection and trending reports prepared by vendor.
- Participate in FDA PV inspection and prepare responses to PV observations.
- Oversee processing of returned complaint samples in database.
- Interact with Global PV affiliates in medical discussion.
Skills And Qualifications
- MD/RN/PharmD and 5+ years of pharmaceutical industry experience.
- Current and complete familiarity with FDA and ICH regulations and guidelines related to Adverse Events and Pharmacovigilance practices.
- Extensive familiarity with key tools such as MedDRA, MedWatch, XML and Periodic Adverse Event reporting formats.
- Data organization skills required; must be comfortable with databases and MS Excel.
- Detail oriented and multi-tasking ability.
- Global interaction with all PV affiliates daily.
- Excellent written, verbal, and interpersonal communication skills.
- Some travel required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Tong at (+!) 646-878-6308 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
ProClinical is partnering with a leading global biotechnology company
ProClinical is advertising a vacancy for a Drug Safety Manager