Clinical Study Physician

Skill: Clinical Study Physician

Job Code: 374081

Location: Mumbai/Bangalore/Noida

Shift: General Shift

Band: BPO 3/4/5/6

Salary Range: LPA

Educational Qualification: MBBS and/ or MD

Required Technical Skill Set:

Literature:

• Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion n DSR (Drug Safety reports).

• Provide MAH comments for selected literature

• Review of Literature Strategy

• Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses.

• Thesaurus used for indexing medical scientific literature, relevant for literature search strategy tailoring (both ad-hoc and systematic).

• Review and interpretation of current expert therapeutic guidelines for the purpose of various safety analyses.

• Review of outputs triaged by the safety scientist for scientific accuracy taking into consideration all of the above criteria

Aggregate Reports:

• Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER (e. g 5.2.4, 6.2, 9.2, 15 & 16).

• Providing MAH comments to literature presented under literature sections.

• Authoring of RMP updates & implementation plans.

• Asses the new information received on important safety concerns for the medicinal product

• Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy

Signal Management

• Review of various types of listings for Signal Detection

• Understanding of signal journey and knowledge of signal management systems and process requirements.

• Perform Signal validation with a summary.

• DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusion and Review

• Tailoring strategy and methodology for signal assessment

• Overall assessment of the signal based on the presented data and respective recommendations for action

• Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy

Project Management

• Manage customer interface, communication and deliverables for assigned molecules/documents/deliverables.

• Tactical, day-to-day customer-facing leadership at project/program level. Responsibilities include project strategy, planning (timelines, deliverables), scope management and project financial management.

• Lead internal escalation meetings to ensure quick response to any quality concerns or customer escalations, ensuring appropriate representatives from stakeholders and operational management are involved as appropriate.

• Lead meetings with internal and external stakeholders

General Knowledge and Skills

• Knowledge of relevant regulatory & scientific guidelines

• Ability to present / communicate effectively with stakeholders on safety topics.

• Ability to speak up effectively and ensure that questions and unclarities are addressed or negotiate/adapt the plan for the work.

• Knowledge across responsibilities of relevant stakeholders and process.

• Ability to work in a team with different stakeholders.

• Prioritize and delegates tasks based on the importance of the deliverables and awareness of overall timelines.

• Providing training with respect to medical aspects of drug safety to various stakeholders.

• Attending and presenting at medical scientific conferences or publishing [optional, outside of scope of responsibilities]

Responsibility of / Expectations from the Role:

• Provide mentorship, oversight and training of less experienced colleagues.

• Have a good understanding of all in scope processes.

• Contribute to all signal management activities with medical expertise, i.e. contribute to detection, validation, DSR strategy and SME review, from time-to- time author parts of DSRs e.g. conclusion.

• Confidently participate in report kick-off meetings and other meetings, as necessary.

• Review of Clinical Study Reports (CSRs) safety sections and narratives for CSRs or health authority requests.

• Provide expert medical input to aggregate reports and other processes.

• Support Health Authority requests with medical expertize, including review and authoring of critical parts as/if necessary.

• Lead or contribute to process improvement and technology / innovation activities.

• Participate in internal and external audits and inspections, as required

Expectation of working in A Matrix Model

• Take proactive ownership of delegated molecule safety activities, contributing to ensuring patient safety and the molecule's safety strategy, i.e. proactive suggestions for SRP, DSR strategy, addressing SRR topics.

• Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action) /deliverables

• Consistently delivering quality the first time across processes *Showing a thorough understanding and competency how the different pharmacovigilance processes connect *Excellent collaboration and leadership to cross-functional safety teams

• Independence, ownership and high competence in the conduct of all Clinical safety science responsibilities