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Job Details - Development, authorship and tracking of Safety Reports (PSUR/RMP/ACOs) to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely manner. Initiates the tracking of commitments and liaises with relevant functions that maintain and monitor the commitments.
- Responsible for the implementation of operational tasks in the field of Safety writing
- Overseeing the service performance
- Mentoring employees enabling them to work independently within timelines, budget, and quality
- To organize the kick off meeting, prepare PSURs & RMP’s as per the client’s SOPs and working practices, review of the document for medical cohesiveness, characterization of safety concerns, to ensure quality of the draft during preparation of RMP/PSUR/ACOs
- In collaboration with required teams, development and authorship of high quality and regulatory compliant PSUR-PBRER, RMP, ACO & DSURs
- Coordinates activities from the different line units to ensure all documents required to support the RMP/PSUR/ACO main document are included in the annexes
- Manage all logistical aspects related to the timely development of the safety reports, work with authors of the different line functions to ensure the content meets client and Health Authorities requirements.
- Updates the RMP according to HA requirements and make sure they are aligned with other regulatory documents such as the Periodic Safety Update Report (PSUR), CDS, etc.
- Ensure consistency and regulatory compliance of RMP/PSUR/ACO sections and annexes.
- Tracks Health Authorities feedback and assessment on RMP/PSUR/ACO and ensures HA requirements are implemented as required (e.g. in individual RMP, in global RMP template)
- Provides expertise required for the finalization of the RMP/PSUR/ACO and its annexes. Resolve issues as they arise. Ensures proper maintenance of all RMP/PSUR/ACO documents as per process
- Develops and dispatches product-specific training slides for both internal and training of 3rd party, and ensure RMP/PSUR/ACO approved by HA or RMP/PSUR/ACO updates are dispatched as per requirement
- Peer-review (data and scientific review) & populate QC checklist
- To address the comments by the various stakeholders.
- Preparation of response to questionnaire to address HA request, Evaluation of the safety database/literature/CT data/epidemiology data to address HA response/request
- Formulating strategy for safety issues/response to health authority requests and integrated benefit-risk evaluation.
- To address the comments by the various stakeholders.
Educational Qualifications:
- Degree in Medicine (MBBS / MD required).
Experience & Skills:
- Minimum 5-7 years of relevant experience in pharmacovigilance and drug safety.
- Hands-on experience in medical review of Aggregate Safety reports, ICSRs, regulatory compliance, and signal detection.
- Strong interpersonal and organizational skills with a collaborative mindset.
- Ability to work under pressure with high responsibility and dedication.
- Exposure to corporate pharmaceutical or life sciences environments is preferred.
- Excellent written and verbal communication skills in English.
- Knowledge of safety databases, regulatory guidelines, SOPs, and literature surveillance.
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Core Competencies:
- Clinical judgment and analytical skills for drug safety evaluation.
- Leadership and mentoring capabilities for guiding junior PV team members.
- Proficiency in global regulatory frameworks and GxP compliance.
- Strong service orientation and proactive problem-solving approach.
What Cencora offersBenefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full time
Affiliated CompaniesAffiliated Companies: PharmaLex India Private Limited
Equal Employment OpportunityCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
