Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.
Under minimal supervision this role is responsible for providing assistance to compliance team for ensuring oversight and monitoring of the Pharmacovigilance (PV) System for local, regional, and global PV based on the principles of Good Pharmacovigilance Practice (GPvP) for Valeant’s pharma, consumer and medical device products.
Assist in Implementation of quality policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations by interpreting federal and state and/or international regulations as they apply to products, processes, practices and procedures
-Complete NC/CAPAs under the supervision of the manager. Prepares responses and monitors commitments to internal audit and regulatory inspection findings.
-Assist with document delivery and preparation during to internal audit and regulatory inspection
-Performs root-cause analysis of any non-compliance reporting GPRM/GPPS process and training standards are effectively implemented, appropriately documented and consistent with departmental, organizational, corporate and regulatory requirements.
-Assist in the development of departmental SOP’s and WI’s including but limited to initiating the document change control process for new departmental procedures and also updating the current procedures.
-Perform Metrics Compliance reports to ensure compliance with regulatory requirements and SDEAs.
-Assist with NC/CAPA and enter them in the system as needed.
-Write User Acceptance Test scripts for data migration, system upgrade and validation of Pharmacovigilance safety system
Maintain current knowledge of the assigned products and current regulations governing the processing and reporting of safety data, Standard Operating Procedures and Work Instructions.
Bachelor’s Degree in science or health related field.
Drug Safety Case processing and safety database knowledge highly desirable
Knowledge of medical terminology (MedDRA).
Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment.
Clear, effective written and verbal communication skills.
Ability to work under pressure in order to meet tight deadlines.
Knowledge of the current regulations on drug safety reporting.
Good interpersonal skills (i.e. team player).
Strong attention to detail along with the ability to meet deadlines.
-Excellent time management skills.
-Strong interpersonal skills and ability to interact with all levels of the organization
-Ability to work well in a matrixed, global team environment
Minimum of 3-5 years pharmaceutical industry
PC skills to include solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint required).
Safety Database experience (Preferably ARIS)