Director of Pharmacovigilance

A career with our Clients is more than a job. Their goal, to discover, develop, and commercialize novel therapeutic products, takes a special type of person. If you're passionate about your work, motivated by a challenge, and deeply committed to what you do, you'll find like-minded individuals with our Clients company. Their environment cultivates innovation--empowering those who want to make a contribution, pursue new ideas and expand their minds along the way. They provides a culture that lives by its values of Respect, Teamwork, Integrity and Commitment, making it a great place to develop professionally Director of Pharmacovigilance As part of the significant growth in evolving into a commercial organization, our Client is looking for a talented Pharmacovigilance leader to build the PV function.  If you want to impact how a company approaches PV, create processes/strategy for PV as a product approaches launch, help bring an orphan drug to market, and build a team to help accomplish these exciting milestones, then keep reading.  They are looking for a leader, not just an individual that can execute pre-defined processes.  Working with Senior Management and other members to develop, harmonize and optimize Pharmacovigilance (PV) efforts within the company. You will be responsible for ensuring that PV has systems and resources to ensure accuracy and compliance with US and international regulatory agency requirements. Job Description and Responsibilities:   Manages day to day functions of PV operations for Clinical Trial and Post marketing Safety Ensure that all case reports are processed and reported in a timely fashion, as per applicable regulations, for both clinical trial and Post marketing safety Serves as collaborative team member on cross-functional product development teams acting as a the PV representative for Safety issues and operations  Works closely with project teams and management to establish philosophy, policies, and processes to meet PV requirements in the US and globally Serves as PV expert for software system identification, evaluation, selection, and implementation Prepares and maintains the content of quality system documents related to Safety processes, (i.e. Policies, Standard Operating Procedures, Work Instructions) Prepares Safety training materials and conducts company-wide training on PV requirements and systems Reviews PV agreements and contracts Maintains relationships with contractors involved with Safety functions Oversees the preparation and collection of various metrics reports to be provided to management Provides support and information to staff for safety queries and DSMB activities Prepares Periodic Safety Update Reports and FDA Period Reports Develops and maintains core safety data information Prepares for internal and external audits; coordinates PV inspectional activities and responses Assists in the preparation of the Safety sections for various company documents (i.e. IND reports, Investigator Brochures, Clinical Study Reports, Integrated Summaries, and special requests by regulatory agencies) May review safety information in the labeling for marketing material Participates in timeline development and long-range planning for PV Evaluates and identifies resource needs and assists with the PV budget Interacts with the Regulatory groups to ensure that cross functional processes are efficient and to foster an environment of shared knowledge, group learning, and team success Maintains and communicates knowledge of PV trends and literature Expected to involve direct supervisory responsibility Other responsibilities, as required Knowledge and Skills Required:  PhD or MS in relevant scientific discipline is preferred; BS or equivalent required A minimum of 3 years management experience and 5+ years safety/PV within the pharmaceutical/biotech industry is required Must be skilled at coding in MedDRA Must be skilled using a major Safety database Must have established mastery in PV processes and thorough knowledge of the US and EU Safety regulations Excellent computer skills, including word processing, spreadsheets and graphic presentations. Excellent verbal and written communication, organizational, and time management skills Mastery of English language (spoken and written) A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments Excellent interpersonal skills with application of negotiation skills, influencing and conflict management to assure effective interactions within and across departments Demonstrated leadership skills   MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: Boston, MA JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee JOB REFCODE: EB-5208966114 COMPANY: Dennis Partners