Associate Director, Safety Physician (gn)

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Deutschland |

Permanent

Job title: Associate Director, Safety Physician (gn)

Duration of employment: Unlimited

Industry: Pharma

Skills: Medizin, Safety Physician, Drug Safety / Pharmacovigilance

Ideal starting date: asap

Location: Deutschland

Tasks:

This role supports the product safety team in all aspects of pharmacovigilance and risk management activities, both marketed and in development
Medical analysis and decision making for the development and maintenance of the Company Core Data Sheet, ad hoc aggregate safety reports, periodic safety update reports (PSURs), signal detection activities and risk management plans (RMPs/REMS) and individual case safety reports.
Conduct product signalling
Timely action and communication of findings in safety governance forums
Present at, or lead, internal safety governance bodies (Safety Management Team, Joint Safety Management Team). Active contributions to internal and external forums (e g., Data Monitoring Committee, Advisory Boards)
Contributing to and reviewing of 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
Participation in audits and inspections as required and contribution to scientific publications, presentations and workshops
Active, regular utilization of data review, reporting and visualization tools & systems
Interacting with Agencies such as FDA and EMA as well as NCAs, Affiliates, partner companies and service providers
Work extensively with colleagues from across the globe
Participate in department decision making and strategy
Ensure all activities are of the highest safety and ethical standards

Qualifications:

• University degree in Medicine (Medical Doctor)

• At least 2 years of experience as a safety/PV professional, preferably in a global pharmaceutical company.

• Good understanding of the clinical practice. Working experience with patient care preferred

• Experience with both developmental and post-marketing products 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 with risk management, aggregate reports and signal detection

• Medical writing experience

• Experience with Regulatory Authority Inspections (PV and GCP);

• Excellent strategic decision-making and analytical skills

• Excellent command of the English language

• Team player with excellent communication and interpersonal skills. Strong presentation skills

• Self-starter with proven ability to thrive in a fast-paced team environment handling multiple simultaneous high priority tasks

• Computer literate, especially in the Microsoft Office product rang; document management and safety database skills are preferred

Referenznummer:

Branche:

Beginn des Projekts:

Dauer:

Anstellungsart:

Kontakt

Marco Bannier

m.bannier@aristo-group.at

+43 1 39505930

13393

Pharma

20.07.2023

n. A.

Permanent