Medical Advisor - Pharmcovigilance

Medical Advisor - Pharmcovigilance

Minimum Qualification - MBBS

- Provision of medical advice to client companies with regard to all pharmacovigilance-focused aspects.

- Creation of PSURs (Periodic Safety Update Reports) and associated documents such as Addendum to the Clinical Overview.

- Single case management with regard to adverse drug reaction reports arising from clinical trials, spontaneous reports or literature, expedited and non-expedited reporting of adverse drug reactions via e.g. the internet-based service Vigicare- and the EMA webtrader.

- Creation, review and submission of ICSRs/CIOMS-I forms.

- Identification of safety-relevant publications in the scientific literature.

- Creation of response documents in reply to authorities' assessment reports to PSURs and in the course of marketing authorization application and/or renewal procedures.

- Creation of various scientific statements focused on individual questions regarding safety-related aspects of drugs (e.g. Risk Management Plans, Signal Detection Reports).

- Writing and review of scientific and medical reports.

- Preparation and review of Clinical Expert Statements.

- Communication with regulatory authorities.

- Review of literature and review and summary of large safety data sets and presentation of results in draft reports.

- Development and review of documents such as RMPs, DRMPs, ad-hoc responses and PSUR and IB contributions.

- Signal detection.

- Safety and benefit-risk evaluations for assigned products.

- Management of potential safety issues for assigned products.

- The Medical Advisor will evaluate the respective databases for safety signals and, in collaboration with other Medical, formulate responses to regulatory inquiries on product safety issues.