HEATHER B. DOUGLAS, RN, MS
Pottstown, PA 19464 firstname.lastname@example.org www.linkedin.com/in/heatherdouglas1
Product Safety/Pharmacovigilance professional with extensive knowledge of federal regulatory requirements for safety surveillance. Resourceful, energetic, and detail-oriented with excellent leadership skills including team building, mentoring and creating a positive work environment. Well versed with regulatory requirements and reporting timelines for adverse events to FDA, MHRA and EMEA. Comprehensive knowledge in handling Individual Case Safety Reports (ICSR’s). Quick learner who really enjoys new and different challenges. Key strengths are creativity, confidence, enthusiasm and ambition.
T-Mobile, Allentown, PA (Contract through Spectraforce Technologies) 2019
Law Enforcement Relations Associate
Classified legal demands (subpoenas, search warrants, and court orders) for telephone records so that they could be processed for lawyers, police officers, etc.
Cherrydale Farms 2018
General Office Associate
Entered numerical data into database in a timely and accurate manner. Inspected database errors and resolved discrepancies. Verified accuracy of data before and after entry into system.
Family Promise - Start up shelter for homeless families 2018 - present
Special Data Process Volunteer
Gives support to the director in data management, donor support and organization.
Karyopharm Therapeutics, Newton, MA (Remote contract through Advanced Clinical) 2016 - 2017
Wrote safety narratives in accordance with company Standard Operating Procedures (SOP) and guidelines for maintaining regulatory compliance. Reviewed colleagues’ narratives for quality.
Telerx, Horsham, PA 2014 - 2016
Evaluated and processed ICSR’s from clinical trials, marketing activities and scientific literature, in accordance with company Standard Operating Procedures (SOP) and guidelines for maintaining regulatory compliance.
Reviewed colleagues’ reports and made revisions as requested by the client.
During upgrade from Argus 5 to Argus 7, my team had to work overtime to process cases before and after the upgrade. The client was elated and praised us for getting the work done inside deadlines.
Johnson & Johnson, Horsham, PA 2004 - 2014
Senior Drug Safety Associate
Evaluated and processed ICSR’s from clinical trials, marketing activities and scientific literature, in accordance with SOP and regulatory compliance for several therapeutic areas. Processed ICSR’s for the following teams: Remicade, Reopro/Retavase (Cardiology), Ortho-cyclen/Ortho-tricyclen (Women’s Health), Procrit, Paliperidone (Central Nervous System), Anti-Infective, Invokana (Diabetes) and Telaprevir.
Triaged adverse events to determine priorities. Reviewed Remicade, Reopro/Retavase and Ortho-cyclen/Ortho-tricyclen colleagues’ reports, conducted weekly literature search and assessed and recommended articles for the teams to guarantee accurate medical information.
Selected by manager as the acting cardiology team lead during the team lead's absences.
Mentored newly hired drug safety associates and coordinators for the Remicade and Reopro/Retavase teams.
Trained a drug safety associate to conduct the weekly Remicade literature search and assess articles.
Served as Co-Team Lead of the Reopro/Retavase Team which split from the Remicade Team.
Received award for leadership on the Reopro/Retavase Team.
Bristol-Myers Squibb Company, Hopewell Township, NJ 1999 - 2004
Regulatory Safety Associate
Evaluated and processed ICSR’s from clinical trials, marketing activities and scientific literature, in accordance with SOP and regulatory compliance for several therapeutic areas. Processed ICSR’s for the following teams: Anti-infective, Oncology, Cardiology and Metabolic.
Triaged adverse events to determine priorities. Reviewed Anti-infective, Oncology, Cardiology and Metabolic colleagues’ reports.
AstraZeneca, Wayne, PA 1998 - 1999
Lead Product Safety Associate
Evaluated and processed ICSR’s from clinical trials, marketing activities and scientific literature, in accordance with SOP and regulatory compliance for Cardiology. Processed ICSR’s for the Cardiology team.
Served as a resource and as a “go to” person for the Cardiology team.
Triaged adverse events to determine priorities and reviewed Cardiology colleagues’ reports.
Supported team approach through participation on the team building committee.
IBAH, Blue Bell, PA 1997 - 1998
Safety Surveillance Specialist
Assigned to Wyeth Pharmaceuticals to evaluate and process Fen-Phen (fenfluramine/phentermine) ICSR’s and assess regulatory status. Evaluated and processed ICSR’s marketing activities with company.
Olsten Health Services, Philadelphia, PA 1997
Manager of Clinical Practice for Maternal/Child, Pediatric and Diabetic Program
Mentored, trained and managed field staff. Assisted in recruitment of potential field staff employees. Served as clinical case manager working with physicians, nurses, therapists and social workers. Coordinated scheduling of maternal/child, pediatric and diabetic referrals and assigned clients to the appropriate field staff employee. Assessed client’s clinical record for quality assurance and improvement.
Allegheny University Hospital - Hahnemann, Philadelphia, PA 1991 - 1997
Registered Nurse/Clinical Associate
Provided quality professional nursing care to antepartum, postpartum, gynecological and neonatal clients in a variety of transitional and high-risk settings. Provided mentoring to new employees and nursing students. Member of department-based clinical practice and education committee. Certified in intravenous insertion, phlebotomy and respiratory therapy. Assumed charge nurse responsibilities when needed.
Served as a lead in developing Tenderfoot heel incision device, a new protocol and device to improve blood draws for newborn infants to decrease pain and bruising of the feet.
Temple University, Ambler, PA
MS in Pharmaceutical Quality Assurance/Regulatory Affairs, May 2002 - Graduated Cum Laude
Villanova University, Villanova, PA - BSN, May 1991
Registered Nurse License (current)