Overall purpose
The Senior Drug Safety Physician provides support to the Global Drug Safety and Pharmacovigilance (DSPV) function (based in Switzerland) in relation with clinical studies conducted and/or sponsored by DNDi (conducted in Africa, Latin America, Asia, India and other regions) and overall drug safety/pharmacovigilance expertise, and contributes to the development and registration of new treatments for Neglected Diseases.
This role oversees clinical safety activities on studies/programs assigned to the Senior Drug Safety Physician and provide medical expertise to the DSPV team.
Specific job responsibilities
Tasks and responsibilities
The Senior Drug Safety Physician will be responsible for the following clinical safety activities, primarily (but not exclusively) concerning assigned clinical studies/activities:
Support the Head of Drug Safety and Pharmacovigilance (DSPV) in ensuring that all Pharmacovigilance -related activities related to the management of DNDi-sponsored clinical studies are performed by trained personnel and compliant with applicable local/international safety reporting requirements
Bring medical expertise to drug safety activities for assigned trials and products.
Provide support for Drug Safety Scientists (non-medically trained) and other Drug Safety Physicians in the DSPV team
Assist the function Head in training and mentoring DSPV team colleagues including on interpretation of clinical safety data and analysis preparation and safety risk management activities
Subject matter expert in clinical safety data interpretation, clinical safety analysis preparation/ Benefit/risk assessment within Periodic safety update reports (together with product/trial medical responsible and DSPV Head), or Subject matter expert in signal detection activities, safety risk management activities and safety profile/safety reference information maintenance
Subject matter expert in interpretation of regulatory aspects of clinical safety/pharmacovigilance
Regular collaboration with other DSPV team members and Pharmacovigilance services providers, Clinical Research Organizations (CROs), DNDi regional offices and Disease/clinical program leadership
Act as Drug Safety Product/Project Responsible (DS PR) for assigned product/project (s):
Coordinate the Product Safety Monitoring Sub-Team (PSMT) related to assigned product(s)/projects.
Coordinate the signal management activities, development risk management activities related to assigned product(s) in collaboration with clinical team/PSMT members and as necessary, other PV team members.
Coordinate the preparation of development Risk Management Plan (dRMP) and evaluation of safety data and benefit-risk assessment in collaboration with clinical team/PSMT members and as necessary, other PV team members.
Propose Pharmacovigilance / Risk management (PV/RM) activities for important identified and potential risks to the PSMT and DNDi Drug Safety Committee (DSC).
Contribute to the maintenance and update of safety profile information and safety reference documents related to product(s) assigned to the incumbent in collaboration with clinical team/PSMT members and as necessary, other DSPV team members or partners.
Contribute to marketing authorization registration dossier from a drug safety perspective.
Act as CT Clinical Trial Drug Safety Representative(s) (CT DSR) for assigned clinical trials:
Coordinate serious adverse events/other Individual Case Safety Reports (ICSRs) medical review and assessment for assigned trials and as per Safety Management plans.
Ensure the availability and approve study-specific safety management plans and SAE reconciliation plans for the assigned trials, prepared by the PV Service Provider.
Review of safety cases line listing (LL) and preparation/review of periodic safety reports (i.e. DSUR) and contribution to study-specific periodic progress reports.
Contribution to study -specific PV training materials and safety-related sections of study documents together with other DSPV team members and in collaboration with clinical team members.
Support the DS Product/Project Responsible on drug safety activities related to the product: contribution to evaluation of safety data, benefit-risk assessment and dRMP preparation and proposals for PV /risk minimization activities.
Contribution to the preparation/update of PV standard operating procedures, working instructions and templates.
Support the global DSPV function in ensuring that all drug safety-related activities related to the management of DNDi-sponsored clinical studies are performed by trained personnel and compliant with applicable local/international safety reporting requirements.
Regular collaboration with other DSPV team members and PV-services providers, Clinical Research Organizations (CROs), DNDi regional offices and Central clinical program leadership.
Contribution to other DNDi functions from a drug safety perspective.
The above list of responsibilities is not exhaustive, and you may be required to undertake other responsibilities appropriate to your grade.
Reporting line
Head of Drug Safety and Pharmacovigilance based in Geneva, Switzerland
Interactions
Works with clinical teams/program teams, and potentially all units in the R&D department involved in assigned trials/programs.
Works with the DNDi global PV services provider, DSPV Intervenors and concerned Clinical Research Organizations.
This role promotes programs and maintains productive relationships by projecting the image of a credible partner and ensures commitment of partners.
Job requirements
Skills and attributes
Very strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines.
Very clear and systematic thinking that demonstrates strong judgment and problem-solving competencies.
Very strong communication skills in multicultural, multi-lingual environments.
Experience
Over 10 years in Senior role
Proven ability to work effectively in a team environment and matrix structure.
Experience of working in public and private sector is highly desirable.
Proven track record in as drug safety physicians contributing to drug safety, pharmacovigilance.
Technical skills
Excellent knowledge of Pharmacovigilance (pre- and post-marketing) and Clinical Research/Development
Excellent knowledge of Regulatory (GCP, GLP and GMP)
Education
Medical doctor
Other requirements
Fluency in French and English a must
Proficiency in other languages an advantage (Spanish, Portuguese…)
Good knowledge of Microsoft Suite
Other information
One year full-time employment contract, renewable
Location: UK or Germany (remote) or one of these DNDi office locations (hybrid): Brazil, Democratic Republic of the Congo, India, Japan, Kenya, Malaysia, South Africa
Apply via :
dndi.my.salesforce-sites.com
