Auftragsdetails

As Senior Pharmacovigilance Consultant at ProPharma Group you will be responsible for and working on multiple projects from a variety of Pharmaceutical, Biotechnology and Medical Device companies and service partner. You will lead and be accountable for a variety of Pharmacovigilance tasks, service delivery, continuous improvement, customer relationships and engagement. You will mentor and advise team members and support key Department and Organizational projects.

Essential Functions Include:

•  Accountable for the implementation of global and local PV services for clients and overseeing successful service delivery from operational perspective.
• Assuming positions for customers like the EU Qualified Person responsible for Pharmacovigilance (EU-QPPV) or the Local contact Person responsible for Pharmacovigilance (LPPV) which may include the Graduated Plan Officer in Germany.
• As the Subject Matter Expert for key global PV Process(es), you will:
  • Create and maintain appropriate and accurate documentation.
  • Ensure that processes are efficient, high quality and in compliance to legislation.
  • Train, assess and ensure compliance.
  • Support internal and external engagement on the subject.
  • Engage in continuous improvement.
• Where required, take responsibility for and lead:
  • receipt, processing, reporting, follow-up and reconciliation of adverse event reports from any source like clinical trials, literature, post-marketing and pharmaceutical-technical complaints.
  • Creation and maintenance of Pharmacovigilance System Master File, Risk Management Plans, Periodic Aggregate Safety Reports (e.g. PBRERs, PSURs, DSURs).
  • Implementation and management of signal detection activities.
  • (Pharmaco-)Vigilance advice on medicinal products and medical devices.
  • Management of activities related to clinical trials, e.g. development of Safety Management Plans.
  • Regulatory intelligence review and compliance for clients and ProPharma Group.
  • Implementation and evaluation of global and local literature searches.
• Leverages network and relationships to identify opportunities to expand service provision to existing and new clients. Leading and supporting acquisition activities including services, positioning, resourcing, pricing, and presentation.
• Take responsibility for the preparation and adherence to pharmacovigilance-relevant Standard Operating Procedures, client Working Practices and associated Work Instructions.
• Prepare and negotiate Pharmacovigilance Agreements/Safety Data Exchange Agreements.
• Identify, engage and oversee PV Alliance Partners performing activities on behalf of ProPharma Group.
• Development and delivery of PV training.
• Effectively lead client audits and inspections.

Qualified candidates must have:

• Bachelor or master’s degree in life sciences.
• Candidate must have fluent written and spoken English language skills.
• Knowledge of EU and local pharmacovigilance regulations and guidelines.
• At least 8 years’ experience within the pharmacovigilance disciplines in the pharmaceutical industry, government agency or a pharmaceutical consultancy/outsource organization or equivalent experience (such as Regulatory Affairs, Medical Information etc.) within the pharmaceutical industry, government agency or a consultancy/outsource organisation would also be considered.
• Experience in effective and results orientated project leadership.
• Management or Supervisory experience would be considered an advantage.
• Excellent communication and strong interpersonal skills:
  • Able to liaise and negotiate efficiently with client companies to ensure the client needs are met.
  • Able to work within a team in an open and professional manner.
  • Able to liaise and negotiate efficiently with internal departments to facilitate delivery of services.
  • Ability to influence change.
• Act as a positive and engaged role model and mentor to others.
• Strong focus on continuous improvement of processes, procedures, business activities etc. 
• Ability to proactively identify efficiencies and provide the business case for change.
• Ability to proactively identify issues or potential issues and offer solutions.
• Sound planning, prioritizing and organizational skills.
• Excellent written and oral communication skills and computer literacy.
• High level of accuracy and attention to detail.
• Proactive and positive approach.
• Ability to manage multiple projects.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***