Manager - Drug Safety
Hawthorne, NY Posted: 4/11/2019
Our client is a research-based international pharmaceutical company that develops proprietary and off-patent pharmaceuticals for markets. The Company produces a wide range of prescription and over-the counter products including tablets, capsules, suspensions, solutions, creams, and ointments. They are seeking a Manager of Drug Safety to join their team of professionals in New York.
MANAGER, DRUG SAFETY
Directly responsible for executing U.S. Adverse Event and pharmacovigilance activities as required by FDA regulations. Coordinates Adverse Event and pharmacovigilance activities for Company sites worldwide. Provides support and oversight in related Drug Safety activities including Product Quality Complaints and Medical Information activities.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Responsible for receiving, evaluating and filing adverse event reports on marketed and investigational products.
- Communicate directly with patients, pharmacists, physicians, Company 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 (annual and quarterly) 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; communicate with the manufacturing sites on quality issues; respond to customers on complaints related to Adverse Events, and, maintain records on the status of investigations.
- 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.
- Interact with Global PV affiliates in medical discussion.
OTHER DUTIES AND RESPONSIBILITIES:
- Participate in FDA PV inspection and prepare responses to PV observations.
- Oversee processing of returned complaint samples in database and to applicable manufacturing sites.
KNOWLEDGE, SKILLS/ABILITIES & EXPERIENCE TO DO THE JOB:
- Current and complete familiarity with FDA and ICH regulations and guidelines related to Adverse Events and Pharmacovigilance practices is essential; should have extensive familiarity with key tools such as MedDRA, MedWatch, XML and Periodic Adverse Event reporting formats.
- Ability to discuss and communicate sensitive healthcare information with patients, physicians, pharmacists and regulators.
- Data organization skills required; must be comfortable with databases and MS Excel.
- Excellent verbal/written communication skills, computer skills and attention to detail.
- Medical degree, Registered Nurse or PharmD degree with minimum of 5 years of pharmaceutical industry experience.
- Detail oriented and multi-tasking ability.
- Must possess the ability to work efficiently in a fast-paced environment, and deal effectively with changing priorities
- Travel required for FDA conferences, vendor PV audits and meetings with Company affiliates.
- Minimum of 8 hours per day, with extended hours, as required.
- Global interaction with all PV affiliates on a daily basis.
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