Operations Manager, Pharmacovigilance and Risk Management - Marlborough, MA | Biospace
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Operations Manager, Pharmacovigilance and Risk Management

Sunovion Pharmaceuticals Inc.

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Location:
Marlborough, MA
Posted Date:
8/3/2017
Position Type:
Full time
Job Code:
5933BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Pharmacovigilance,

Job Description

The Operations Manager is responsible for management of pharmacovigilance (PV) procedure and process development and other operational activities to support the PVRM organization in conducting PV activities, and for the management of PV training initiatives and training plans. The Operations Manager significantly contributes to audit and inspection preparation and is a member of a cross-functional working team supporting PVRM audits. The activities above can include liaising with and supporting the corporate office and the Sunovion subsidiaries and affiliates to support global and regional initiatives, respectively
Liaises with PVRM members as applicable in the development of procedures and processes to support the business. Authors standard operating procedures and work instructions, as applicable, to ensure alignment across PVRM functions.
Oversees and provides strategic input into all training initiatives to ensure a coordinated approach to training within PVRM and across the organization, including affiliates and PVRM CRO, as applicable, and ensures that all training materials are compliant with corporate policies, SOPs, and Federal regulations. This includes but is not limited to development and maintenance of individual learning plans, on boarding training for new hires, training materials (e.g., slide decks on regulations, guidance’s), and researching and coordinating in house trainings conducted by third party vendors, and storage of training documentation.
Participates in audit and inspection preparation as part of a cross-functional working team supporting regulatory, internal, and business partner audits.
Manages procedural revisions based on findings, as appropriate.
Manages or assists in ad hoc PVRM or cross-functional projects as applicable

Requirements

Five years’ of experience working in regulatory frameworks (of which at least three years are specific to Pharmacovigilance), 2 years’ experience in procedural document creation or revision, and excellent procedural writing skills.
The individual must have a good understanding of U.S. regulations and a fundamental working knowledge of global regulations, e.g., European & Canadian and ICH guidelines, and practical experience in the interpretation and implementation of PV regulations.
Knowledge of Quality Management or SOP/Document Management Systems is required.
Ability to work effectively in multi-functional teams and be able to work effectively with moderate supervision.
Good verbal and written communication skills are very important; and good computer skills with demonstrated proficiency with MS Office applications, especially Word, Excel and Power Point are mandatory.