PV Physician is primarily responsible for the oversight of and provision of medical input to benefit-risk assessment activities including: ad hoc data analysis in support of internal/external queries; preparation and review of aggregate reports; signal detection and evaluation; support of benefit-risk evaluation efforts; generation and/or review of risk management plans (RMPs), risk evaluation and mitigation strategies (REMS), identification of risk minimisation measures; handling of responses to Regulatory Authority queries, scientific/medical input to other safety related documentation including Health Hazard Evaluations, clinical study protocols, final study reports, dossier documents, Medical Affairs activities, commercial/marketing information, as needed and providing support for product labelling activities.

Main Responsibilities:

Medical Review quality control of medical assessment of individual case safety reports (including coding, seriousness, expectedness, and company causality assessments) done by the vendor.
Contribute to the scheduling of aggregate reports, RMPs and other safety related documents to ensure all required reports are documented on the report calendar.
Provide medical input and/or review of Medical Assessment deliverables including but not limited to aggregate reports including: PSUR, PBRER, PADER, Annual Reports, DSURs and ACOs.
Conduct peer quality review of aggregate reports, and quality review of reports generated by the vendor.
Support the PV Scientists in ensuring all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements.
Provide medical input to signal management activities for assigned products, ensuring signal detection is conducted in a regular, timely manner in accordance with schedule.
Signal evaluation: Validation of potential signals and ensure appropriate actions are taken for confirmed signals.
Summarize findings and present to the Head of Medical Assessment, Regional PV Heads and Glboal Head of Global Pharmacovigilance at appropriate forums such as signal management committee.
Conduct aggregate safety data review on an ad hoc basis to support benefit-risk evaluations.
Provide medical input to RMPs/REMS and aRMMs as required and review RMPs authored by PV Scientists.
Prepare and/or review Health Hazard Evaluations and other ad hoc safety reports as requested.
Contribute to the identification and design of additional risk minimization measures and support their implementation in collaboration with PV Scientists, local affiliates and third-party partners.
Clinical & Regulatory Activities: Provide medical/safety input to other cross-functional documents, including clinical study protocols, study CRF, statistical analysis plan (SAP), coding review, final study reports, dossier documents and other documents required to support filing activities. Participation in product/project team meetings.
Provide safety input, advice and support to commercial, marketing and Medical Affairs activities as required.
Labeling document review: provide medical input to reference safety information, Investigator Brochures, product labels and patient information leaflets to ensure the most up to date and accurate safety information is present in all labeling information.
Regulatory Authority query management: liaise with Regulatory Affairs to respond to PV-related Regulatory Authority queries; coordinate with various stakeholders when finalizing the response, ensure responses are tracked to closure.
Participate in due diligence activities for product acquisitions/divestments as required.
Participate in development of CAPA and take ownership of CAPA completion where assigned.
Participate in regular, scheduled meetings with PV team/service provider/third parties as required.
Support for PV QMS: Support the development and revision of department SOPs and work instructions. And participate in the review of cross-functional SOPs which include reference to PV activities.
Support PV training for new members of PV team and non-PV personnel, particularly product-specific, scientific and medical training.
Act as SME for above activities during audit and regulatory authority inspections, as needed.
Any other activity assigned by Head Medical Assessment.

Relationship Management

Working within PV team and cross-functionally with key stakeholder functions including Clinical, Regulatory Affairs, Medical Affairs, Commercial Teams and Business Units.
Interactions with vendors/service providers for PV activities.

Process Improvement / Standardization

Participate in process improvement initiatives under supervision of Head of Medical Assessment and Global Head of Pharmacovigilance to promote internal audit and regulatory inspection readiness.
Participate in safety database/PV system upgrade activities such as defining user requirements and conducting user acceptance testing.

Qualifications

Education: MBBS preferably with MD

At least 5 years of relevant PV experience after MBBS

Desired Skills & Competencies

Good working knowledge of PV regulations including FDA, EU & local requirements.
Strong data analysis and report writing skills.
Excellent teamwork and interpersonal skills.
Strong problem solving and decision-making skills.

PV Physician-Medical Assessment