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Director, Global Pharmacovigilance - Safety Physician (m/f/d) (DE)

[11126]
Drug Safety / Pharmacovigilance, Safety Physician, Risk Management

Title: Director, Global Pharmacovigilance - Safety Physician (m/f/d) Employment Duration: open-ended Industry: Pharma Skills: Drug Safety / Pharmacovigilance, Safety Physician, Risk Management Ideal Start Date: immediately Region: Frankfurt Aufgaben: ·This role will lead a product safety team in all aspects of pharmacovigilance and risk management activities, both marketed and in development ·The safety physician is responsible for maintaining an up-to-date understanding of the safety profile for assigned products and for the development and maintenance of the risk management strategy ·Primary ownership and accountability for product signaling review analysis delivery and approval ·Proactive monitoring of product safety profile from first in human throughout lifecycle ·Leadership and ownership of internal safety governance bodies (Safety Management Team, Joint Safety Management Team). Active contributions to internal and  external forums ·Timely action and communication of findings in safety governance forums ·Contributioning and reviewing key Pharmacovigilance documents such as PSURs, Risk Management Plans, safety sections of CCDS, SmPCs and other labelling documents, IBs, Clinical Trial/ Study Protocols and Final Reports. Providing expert knowledge to ensure that the documents meet the regulatory requirements ·Participating in NDA/MAA filings, health authority interactions, and FDA Advisory Committee meetings, as applicable. As well as contribute to label development and scientific regulatory responses ·Participation in audits and inspections as required and contribution to scientific publications, presentations and workshops ·Contribute to mentoring and on-boarding of new colleagues ·Interacting with Agencies such as FDA and EMA as well as NCAs, Affiliates, partner companies and service providers ·Serve as the subject matter expert from a safety perspective ·Participate in department decision making and strategy Qualifikationen: ·University degree in Medicine (Medical Doctor), current medical license preferred ·Demonstrated experience (at least 5-7 years) as a Safety/PV professional in a pharmaceutical or medical device industry ·Ability to act as in-house authority/leader in Safety and Pharmacovigilance, and be fully accountable for Safety of assigned products ·Experience with both developmental and post-marketing products preferred and in interacting with global regulatory authorities ·Solid knowledge of EU and FDA as well as main global PV regulations. ·Knowledge of clinical trials, good clinical practices, and ICH guidelines ·Experience in working in a global setting ·Excellent verbal and written communication skills in English ·True team player with strong leadership skills ·Statistical and epidemiological knowledge a plus ·Good presentation skills

Title: Director, Global Pharmacovigilance - Safety Physician (m/f/d)
Employment Duration: open-ended
Industry: Pharma
Skills: Drug Safety / Pharmacovigilance, Safety Physician, Risk Management
Ideal Start Date: immediately
Region: Frankfurt

Aufgaben:
  • This role will lead a product safety team in all aspects of pharmacovigilance and risk management activities, both marketed and in development
  • The safety physician is responsible for maintaining an up-to-date understanding of the safety profile for assigned products and for the development and maintenance of the risk management strategy
  • Primary ownership and accountability for product signaling review analysis delivery and approval
  • Proactive monitoring of product safety profile from first in human throughout lifecycle
  • Leadership and ownership of internal safety governance bodies (Safety Management Team, Joint Safety Management Team). Active contributions to internal and  external forums
  • Timely action and communication of findings in safety governance forums
  • Contributioning and reviewing key Pharmacovigilance documents such as PSURs, Risk Management Plans, safety sections of CCDS, SmPCs and other labelling documents, IBs, Clinical Trial/ Study Protocols and Final Reports. Providing expert knowledge to ensure that the documents meet the regulatory requirements

  • Participating in NDA/MAA filings, health authority interactions, and FDA Advisory Committee meetings, as applicable. As well as contribute to label development and scientific regulatory responses

  • Participation in audits and inspections as required and contribution to scientific publications, presentations and workshops

  • Contribute to mentoring and on-boarding of new colleagues

  • Interacting with Agencies such as FDA and EMA as well as NCAs, Affiliates, partner companies and service providers

  • Serve as the subject matter expert from a safety perspective

  • Participate in department decision making and strategy




Qualifikationen:
  • University degree in Medicine (Medical Doctor), current medical license preferred
  • Demonstrated experience (at least 5-7 years) as a Safety/PV professional in a pharmaceutical or medical device industry
  • Ability to act as in-house authority/leader in Safety and Pharmacovigilance, and be fully accountable for Safety of assigned products
  • Experience with both developmental and post-marketing products preferred and in interacting with global regulatory authorities
  • Solid knowledge of EU and FDA as well as main global PV regulations.
  • Knowledge of clinical trials, good clinical practices, and ICH guidelines
  • Experience in working in a global setting
  • Excellent verbal and written communication skills in English
  • True team player with strong leadership skills

  • Statistical and epidemiological knowledge a plus

  • Good presentation skills

map Raum Frankfurt date_range ab sofort update Permanent
Direct contact

Marco Bannier

Associate Senior Consultant
mail m.bannier@aristo-group.com
phone +49 89 599 1827 200


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