Assistant manager, Pharmacovigilance, Epidemiology & Risk Management

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Searching literature databases and screening database hits for new safety data onmedicinal products, reportable and non-reportable cases and signal detection.

• Writing Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update
  

Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience
Report (PADER), and Clinical Expert Statements.,

• Publishing, distribution, archiving and submission of safety reports.
• Preparation of Signal detection reports, including EVDAS screening if applicable.
• Preparation of SARs (Signal Assessment Reports).
• Writing Risk Management Plans (RMPs). Identifying safety concerns and providing advice
  

with regard to future risk minimisation activities for the entire life cycle of the product.

• Reviewing the documents, checking for completeness and consistency, and evaluating the
  

report quality. Ensure training compliance. Train and mentor new staff.

• Preparation of responses to PRAC assessment reports and other Authority requests (e.g.,
  

referrals, etc). Collaborate with internal and external stakeholders to clarify expectations and
ensuring compliance with regulatory requirementsThe employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required.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
  

What Cencora offers

Benefit 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 Companies

Affiliated Companies: PharmaLex India Private Limited

Equal Employment Opportunity

Cencora 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