Posted to MedZilla on 9/21/2017


ProClinical

England, Associate Director, Aggregate Reporting DS_JS_13450-MZ


 
 

An internationally known biotechnology company has an opening for an Associate Director, Aggregate Reporting job at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide. The Associate Director Aggregate Reports will be in charge of establishing and leading a team of PV Scientists responsible for aggregate reports for investigational and post-marketing products (i.e., DSURs, PBRERs, RMPs).

Job Responsibilities:

  • Lead and manage the Aggregate Reports team, including forecasting budget/headcount; hiring, training, mentoring staff.
  • Serves as subject matter expert on aggregate reporting safety requirements for PV Scientist Group, SABR and cross-functionally.
  • Establish, improves and/or monitor aggregate report processes and templates, including working cross-functionally to ensure global compliance with aggregate report writing and submission. Oversees and leads process improvements.
  • Understands, interprets, analyses, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
  • Mentors others to develop these skills and provides oversight on deliverables representing this data.
  • Oversees management and authoring of aggregate data reports. Oversees and mentors less experienced PV Scientist staff. Represents and speaks to these processes in cross-SABR and cross-functional forums.
  • Subject Matter Expert in aggregate safety reports; including knowledge of applicable safety regulations.
  • Includes knowledge of case processing, and safety database concepts. Demonstrates ability to mentor others and lead PV Scientists and SABR in decision making impacted by PV and drug development requirements.
  • Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems
  • Strong organizational skills, including the ability to prioritize independently with minimal supervision. Ability to assess resource needs and adapt accordingly.
  • Applies clinical judgment to interpret case information, helps guide staff on clinical judgment and interpretation of case information.
  • Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues. Fosters collaborative relationships and models expected team behaviour.

Skills and Requirements:

  • Minimum 8 years Pharmacovigilance experience, including management experience. 
  • Minimum 3 years’ experience with aggregate safety reports (DSURs, PBRERs, RMPs).
  • Bachelor's Degree in biologic or natural science; or health case discipline
  • Advanced degree (PhD, MPH, NP, PharmD, etc.) required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jon Stewart on +44 203 7520 318 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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