What are the responsibilities and job description for the Manager, Regulatory Affairs position at Pharma Search Partners LLC?
Job Summary
Oversees and assures compliance with standard operating procedures, regulatory standards and guidelines, and operating agreements with co-marketing partners to meet assigned timeframes and assure consistency of case records and documentation.
Key Responsibilities
- Evaluates, tracks, documents, and processes adverse event reports received for assigned product, including timely review and distribution to co-marketing partners and Company affiliate offices.
- Assures follow-up of adverse event reports that potentially impact the safety profile of product area responsibility.
- Provides product information to healthcare professionals, consumers, sales representatives, and other Safety staff for all marketed and investigational Company products.
- Designs and conducts quality reviews to verify accuracy, completeness, and validity of information for adverse event reports for the assigned product area.
- Createssummaryreports for submission to the FDA and International Regulatory authorities.
Essential Functions
- 30% Adverse event information collection, processing, tracking, and distribution; interact with health professionals and consumers regarding post-market adverse experiences, and clinical investigators and their staff regarding AE's from clinical trials.
- 20% Assist in projects requiring review and assessment of medical information obtained or related to adverse event reports, cumulative reports, or international regulatory reports and requests.
- 30% Set standards for data collection and distribution processes; coordinates with others to assure policies are implemented. Assures regulatory and internal timeframes for the processing of adverse event information are met.
- 20% Interface with operational counterparts at Company affiliate and co-marketing partner locations, to assure the procedures and agreed implementation meet respective goals and regulatory responsibilities.
Requirements
- Application of clinical medicine to patient care.
- Medical terminology and standards of patient care.
- Communications, medical writing skills.
- Knowledge of International and US Regulations for reporting Adverse Events for Investigational and Marketed products.
- Minimum 5-7 years experience in an industry application of clinical medicine/pharmacy, including a minimum of 3 years experience in International Product Safety.
- Knowledge of Clinical Development process in Pharmaceutical Industry.
- Experience in verbally interviewing and/or providing medical information to healthcare professionals.
- Bachelor's degree in medical field with RN or RPh licensure, or PharmD/MD degree required.
